[00:00:00] Lars Wilde: And so we met and I had a high dose psilocybin experience. And that within one session actually got me rid of the anxiety disorder and the depression. It was a mind blowing and life changing experience.
[00:00:16] Greg Kubin: Welcome to Business Trip. A podcast about psychedelic entrepreneurship. Psychedelic medicine is transforming mental, physical, and spiritual health and entrepreneurship will be key to expanding access. Business Trip explores the business models and origin stories of the most interesting companies in psychedelics.
[00:00:34] I'm Greg Kubin, and in this episode, I'll be co-hosting with Business Trip's co-creator Matias Serebrinsky. So Matias why did we do an episode on Compass Pathways?
[00:00:44] Matias Serebrinsky: Well, Compass is a mental health company whose initial focus is psilocybin assisted therapy for treatment resistant depression. And it is worth saying that they consider themselves a mental health company first and foremost, not a psychedelic medicine company.
[00:01:01] And, I would say that it's interesting because they are currently in phase 2B clinical trials, and it's basically the only company outside MAPS that is this advanced, when it comes to getting psychedelic medicine through clinical trials.
[00:01:18] Greg Kubin: I'd also add to that, that their protocol is unique in that it combines a synthetic form of psilocybin called COMP360 with psychotherapy where the patient meets with the therapist
[00:01:31] multiple times. And the FDA has never approved a therapy, combining a drug with a therapy before. And yet Compass Pathways has actually received breakthrough therapy designation in 2018, which is only granted when a therapy is significantly better or potentially significantly better than the standard of care
[00:01:49] Matias Serebrinsky: in many ways
[00:01:50] compass kickstarted, the retail investors interest in psychedelic medicine. They were the first company that got listed in the NASDAQ last year.
[00:02:02] Greg Kubin: In this episode, we speak with Lars Wilde, the co-founder and chief business officer of Compass Pathways. And what's cool with Lars is that he's a serial entrepreneur.
[00:02:11] Compass is the 10th company that he's founded.
[00:02:15] Matias Serebrinsky: So Lars was in a way solving his own problem. He was very open about the fact that he discovered psilocybin therapy through his own mental health journey. He suffered from depression and anxiety and found tremendous help in psilocybin therapy.
[00:02:34] Greg Kubin: There were a few other things that I thought were cool about this episode.
[00:02:37] One was how Lars' talks about Compass's focus on scalability and distribution. And it struck me how historically a psychedelic retreat is really a small business. Right. Only seeing a few people at any given time and in Compass' case their psilocybin therapy for treatment resistant depression as their first indication could be prescribed to millions of people.
[00:03:03] And so as they think about the protocol and they think about how they're gonna get it out there. And there's, there's so many fine details that they need to consider. And they're not just thinking about each individual patient, but they also have to think about, well, what does this look like at scale when potentially millions of people are in the system?
[00:03:22] Matias Serebrinsky: I also liked that we kind of nerded out on the clinical trial designs. Um, how nuanced to clinical trials are on how you build this organization that actually has a competitive advantage as you're bringing more medicines to market.
[00:03:39] Greg Kubin: One other specific thing that came to mind about their approach is how they're not just thinking about individual
[00:03:46] therapy, one-on-one but rather group therapy models. And that's something also that has historically been used in the retreat setting.
[00:03:55] Matias Serebrinsky: I'm also happy that we kind of address the elephant in the room. We talked about their IP strategy. He addressed how he's thinking about patents, composition of matter, data exclusivity.
[00:04:09] He'll cover that in the interview. I think they have a very solid strategy there. It was interesting when we got into competition and what other companies can and cannot do. And that will have a lot of implications towards the future of other companies using psilocybin for the treatment of different mental health disorders.
[00:04:31] Greg Kubin: Yeah. It's still very unclear how they. What the landscape will look like in a few years, but what we do know is that Compass has a pretty broad patent strategy. They've have coverage of the composition of matter how their actual crystalline synthetic psilocybin is formulated, paired with the protocols for indications like major depressive disorder and treatment resistant depression.
[00:04:56] But, you know, as we talk about in the episode, they've definitely been scrutinized. And in some instances criticized for their approach. Uh, potentially being too broad. So that was definitely a highlight of the interview for me,
[00:05:13] Just as a reminder, this is not investment advice and is for information and educational purposes only. Yeah. So Matias nor I own stock in Compass Pathways,
[00:05:24] Matias Serebrinsky: but maybe we should.
[00:05:35] Greg Kubin: This
[00:05:35] is actually the first interview that Matias and I are co interviewing. Yeah. Th thus far it's been either himself or myself. And what we realized was that a, we like chatting with each other. And so it's, it's kind of fun to do that. But B you know, in addition to the podcast, we also have been investing in the space.
[00:05:55] And often when we're speaking to founders, It's not just one of us, but it's two of us. And I often find that we compliment each other well, and I'll ask a question and then I often find that like, there's actually maybe a better question or another dimension to it. And so we're kind of experimenting the tag team approach here, which I think will be more fun to. Lars,
[00:06:17] thank you for joining Business Trip for a special interview. I would like to get started with your origin story in terms of how compass pathways came to be.
[00:06:29] Lars Wilde: Yeah. Uh, again, thanks for having me and happy to talk you through the way that Compass came into being with three co-founders Katya, George and me, we have a diverse set of backgrounds. Katya as a physician.
[00:06:41] George is a psychologist by training, but a serial entrepreneur. And I have been an investor in the past and also serial entrepreneur in tech. I have been running and starting tech companies over the past 10 years. And I'm one of these companies that was running as the founding CEO. I employed a lot of my friends, um, and unfortunately five years into the journey,
[00:07:02] one of these friends, very unexpectedly died from a massive heart attack, and very prominently he was the lead singer of a band in a concert. Uh, quite a few of my employees attended that concert and, and called me that night. And, um, At the same time, there were a couple of things in the company that were not going great with the free writing, uh, shareholder.
[00:07:19] And then there were some personal problems as well. And, you know, as so often happens in life, you know, these things sometimes then all happen at the same time. And that left me with my first experience with a mental health disorder, uh, which was a generalized anxiety disorder, uh, as it was diagnosed later with panic attacks.
[00:07:36] And, um, typically, and it was very difficult to stress me out and I'm a very relaxed person, so it just didn't fit my self image. It was running the company as the CEO, and I typically enjoyed spending time with people, but I realized that interacting with people was increasingly stressful. And so I reached out to a psychiatrist friend of mine who first put me on SSRI.
[00:07:54] Um, they didn't do anything for the anxiety disorder, but I think they generally worsened my state. So I became depressed over time, and then moved through kind of the arsenal of, uh, psychiatric treatments, um, was eventually put on tryciclics and with all the side effects that come with it, and that unfolded over the course of a year.
[00:08:11] And, uh, did some therapy and eventually came to the conclusion that I needed to move on from the company where everything reminded me of my friend and I felt trapped in a certain situation. And, um, I, when I decided to leave and hand over the CEO position, I informed my board of directors and my venture capital investors.
[00:08:26] One of these investors was a good friend of mine, Christian Angermayer, who called me immediately and said, Hey, I'm really sorry you're not feeling well. Do you know what psilocybin is? And I'm German. I hadn't heard the word before. I'm a say. And then he said, oh, look into it. Salba Pitsa magic mushrooms in English.
[00:08:40] And to look at the research and if it's interesting, give me a call back. Now, if you suffer with the anxiety disorder, you're very diligent. And so I read everything that I could find, um, over the course of two weeks and I called him back and said, look, I'm convinced. I want to try this. Nothing else has really worked for me.
[00:08:54] And so we met and I had a high dose psilocybin experience and that within one session. Got rid of the anxiety disorder and the depression, there was a mindblowing and life-changing experience. And coming out of it, I still improved over the next couple of days. And I had so many insights in my life and what mattered, what didn't matter.
[00:09:13] Led me to make a lot of changes in my life. And I believe that eventually these changes, uh, led me to never become depressed or anxious again. And I became very intrigued about the prospects of this therapy and thought about, okay, how can we get this to patients? I knew nothing about drug development, but when I was working in growth equity, I started a company that is doing in vitro fertilization.
[00:09:35] Uh, large clinic group in Europe called Vivaneo. So I thought, okay, maybe we can start mental health care centers and then treat people with a nitrous substance in the Netherland. That would not scale. And then luckily again, my friend Christian introduced me to Katya and George, we got introduced to through a common friend and he said, look, they have a very similar story to yours.
[00:09:51] Their son suffered with OCD, anxiety disorder, depression, suicidality, and found tremendous help in ketamine and psilocybin, which got them very involved in funding research in the fields. And they're currently deciding whether they should start a company and develop psilocybin as a medical treatment through the regulatory pathways.
[00:10:08] The next day I hopped on a plane, flew to London. The three of us met together with Christian, got to know each other and decided to build Compass together only a few weeks later. Uh, we then founded the company officially in summer of 2017 and have been building Compass since initially with a very strong focus on treatment resistant depression.
[00:10:27] And psilocybin therapy and we are now going broader into many other, uh, mental health indications. And, uh, yeah, that led me to this place,. Um, at the moment, I'm very much focused on the strategy. What's next for compass? Uh, where are we going in terms of new treatments, new molecules, digital interventions.
[00:10:44] And it's a very exciting time to be in medicine.
[00:10:47] Greg Kubin: It's an origin story where you experienced the problem. And as an entrepreneur felt the heavy inclination and the pull to solve it, not just for yourself, but for others. I guess one question from your own trajectory previously, it sounds like you were working more in tech and compass pathways working on partially pharmaceutical, more like drug development.
[00:11:07] What was that transition like? And I guess, how did you get up to speed quickly on more of the biotech side of things? Like how did you learn the landscape?
[00:11:17] Lars Wilde: Yeah, that is a great question. Because when I initially joined, I was probably in the core of what we were trying to achieve, uh, the least experienced team member.
[00:11:25] What I brought to the team instead of had raised very significant amounts of venture capital funding for my other companies before. And so I brought that angle to composition and I said, look, I'm just going to join you, help you raise the first round of funding. I think you're going to do great. And I was actually thinking about then doing something else.
[00:11:39] So we're thinking about the clinic side of the administration and. And yet I think then I just had phenomenal colleagues that knew what they were doing. They taught me a lot and I'm a strong believer in just a, you know, learning on your own terms. So I bought dozens of books, uh, went very deep into, uh, regulatory, preclinical development, clinical development, and to try to understand what it takes to
[00:12:00] to develop psilocybin. And I think what sets it apart a little bit is that it's not a small molecule development program where you would say, look, you need the expert who has done it a couple of times before. I think from a drug development perspective, that is something completely new to develop a therapy that is integrated indeed with psychotherapy, uh, digital support who would see et cetera.
[00:12:17] So it's a completely new field. And I think that is what you see in any new industry that arises that you have people that are coming from the outside in and changing the status quo. And I think we're seeing the same now in psychedelic therapies.
[00:12:29] Matias Serebrinsky: You seem to have liked the biotech route. You're now an investor in a few companies that are biotechs.
[00:12:35] You're a director in Sutra therapeutics, Quercis pharma. So what is intriguing or interesting for you about biotech?
[00:12:45] Lars Wilde: Yeah. So I love, I've always been in love with science and as I feel like I strayed away from it after high school, by studying business. And I actually still, you know, all the way through, I've always been reading, you know, the nature of science and, and stayed very close to what's happening in science.
[00:13:00] And it was very serendipitous that, you know, starting Compass that led me to dive in, into drug development then, and I see huge opportunities there. I think, um, when we think more narrowly about biotech, I think it's this amazing. Moment in medicine development, where you have the fields of technology.
[00:13:16] And with that, I mean, for example, AI and speed data, advanced modeling, growing together with standard direct development, you have elements of robotics and all of that speeds up and the development process of novel drugs that makes the likelihood of success much higher. So when you have seen the field of drug development over the last 50 years, so you saw a constant decline of drugs that made it to market per dollar spent.
[00:13:38] And I think we're just at the cusp of where this would turn around. And I think over the next 20 years, we will be solving many major diseases through these technological advances. And I think psychedelics are case in point where we didn't discover a psychedelics through any of these new technologies that are now being brought to the feet of medicines development.
[00:13:53] But what we did with it was we are much more closely understanding what psychedelics are doing to the brain on a molecular level, on a cell level or on a network level that has only become possible because of the modern tools that we can use now. So, you know, there's the typical VC question. Why is this happening now?
[00:14:08] Why didn't it happen 10 years ago? Why is it not happening in 10 years? And I think there are a couple of elements that. One of which is, um, the scientific innovation that has happened and a great researchers like Robin Carhart-Harris, is David Knutt and et cetera, showing how psychedelics mechanistically lead to these changes that improve patient outcomes.
[00:14:25] And that made it a much easier dialogue than with regulators to say, look, we know why this might work. And, you know, we want to run large scale clinical trials to prove that that is actually correct.
[00:14:34] I want
[00:14:34] Matias Serebrinsky: to go back for a second to your own personal story. And you mentioned that you suffered from treatment resistant depression and generalized anxiety disorder.
[00:14:45] I think you're the first precedent of a public company that has disclosed, uh, suffering from treatment resistant depression. At least it's not common. How intentional is that? How do you go about it? You know, what has been the reception from the public markets on professional environments around your disorder?
[00:15:08] Lars Wilde: It's a great question Matias, because, uh, I I've, I've never been asked that before, but I, you know, when I came out out of the closet, so to speak with my diagnosis, when I was still running another company Springlane, it was very interesting when I saw the reaction of my investors, because some of them open up about their own mental health issues.
[00:15:23] And then there were speaking about the portfolio companies and how many of the founders are suffering depression and anxiety disorder, OCD, personality disorders, et cetera. So then it became very apparent to me that, you know, I'm not alone, there are many others out there. And so I just make the conscious choice in 2016 that I would always openly speak about it, because I think it's important for people to see that you can fully recover and you can lead a very normal life and that there shouldn't be any stigma around mental health suffering.
[00:15:48] And so I've been very open throughout and it was very interesting because then that also was connected to my psychedelic experience, which I. Um, is maybe the more tricky bit because people would think, oh, you know, psychedelics, it's still an illegal substance treatment modality. And what I realized when I started speaking, especially with American investors, I would say that every second investor would tell me, Hey, it's great
[00:16:09] you're sharing this. Uh, I found a lot of support with Psilocybin, MDMA and they share their own story. So I realized that once I started opening up, others started opening up and this became really a part of our company. And I think that is common across the co-founders that we realized that everybody has a story.
[00:16:24] And what we mean by that is that we know that 25% of people on this planet are suffering with some type of mental health disorder at any point in time. So if you think about it, that that is every fourth person, right? So everybody has someone in their circle of friends and the family that is suffering at this very moment in time.
[00:16:40] And sometimes these people don't speak out about it and I believe that actually worsens the situation. Yeah. So I think it's really important to talk about it. I have only had very positive resonance from investors, employees, any other types of stakeholders. So I hope that, that, you know, this helps others to also come out of the closet and speak about their own suffering and further de-stigmatize mental health problems.
[00:17:01] Greg Kubin: I want to talk about the compass protocol and the patient experience. Um, so your, your first indication that you're targeting is treatment resistant depression, which is a condition where individuals who have depression, but have tried to treat it at least two ways. Unsuccessfully will then be diagnosed with treatment resistant depression and
[00:17:24] that's where I guess you guys would come in as a potential therapeutic. So we'd love to kind of talk through, I guess, a few things. One is the decision to target that indication. And I guess the second would be what the protocol and the patient experience is like.
[00:17:42] Lars Wilde: Treatment resistant, depression. That's a bit of a weird term because it sounds like people are resisting treatment, uh, which is not the case.
[00:17:48] It's, uh, as you said, right, people are not served by the current treatment at the inverse of that is that some people are served by it. And then I think that's important. And that goes to the point of, you know, why treatment resistant depression and not major depressive disorder, which is the umbrella indication.
[00:18:02] The reason for that is that two-thirds of patients respond really well to standard of care, which is SSRI treatments, SNRI treatments, anti-depressants, and it helps them kind of over the hump. They recover from the depressive episode and they go on with their lives. Now, SSRIs and SNRIs are genericized drugs.
[00:18:17] They're extremely afordable. And psychedelic therapy will always be somewhat expensive because of the need of having a therapist present, prepare the patient, work with the patient during the session and integrate the experience afterwards. And therefore we looked at where's the need, the biggest. And so that this is what we found in treatment resistant depression.
[00:18:34] These patients have exhausted kind of the standard of care. And then it becomes very much a guesswork by the psychiatrist where they are then exploring treatments such as atypical anti-psychotics ketamine and other atypical, antidepressants, somatic treatments, ECT, TMS, et cetera. And these patients do not really respond well.
[00:18:51] And that is also where the cost to the system is the highest. So the annual cost of a TRD patient runs somewhere between 17 to 20,000 a year. And that's a perpetuity cost because these patients do not really improve. Now, that is a patient segment where it's very likely that we would be able to get psilocybin therapy reimbursed.
[00:19:08] And that has always been the focus of the company since we started it, that we said, it's all about accelerating patient access to evidence-based innovation and mental health. And the excess pod is really what we're focused on. We believe that only if we can get psilocybin therapy reimbursed at scale. Uh, will the treatment really scale to the global need in TRD?
[00:19:26] That has been the focus in terms of the treatment modality, the original, uh, I would say psychedelic therapy has been developed at Harvard university under Tim Leary and his colleagues in terms of the set and the setting. So we used this model and worked with some of the world's leading practitioners that are active in the academic trials to prepare the patients adequately. The initial focus on us on creating therapeutic Alliance between the patients
[00:19:49] and the therapist, uh, for the therapist to understand the patient's history. And teach the patient a couple of coping techniques for the extra psychedelic therapy session. That's actually then happens in a mental health care facility where the patients in our phase 2B trial works with two therapists, um, a lead therapist and a co-therapist. The drug has given in the form of oral capsules that patient ingests and, um, it's then, uh, invited to lay down on a bed, put on eye shades and earphones and listen to a soundtrack that guides the patient through different emotional states.
[00:20:18] No active therapies happening on the day. The focus there is for the patient to be open to whatever shows up during the experience and stay present with that experience and the therapist. I want you there for support and, you know, for practical things like a bathroom break, if that happens during the session and
[00:20:35] post the treatment day, the patient then enters the final phase, which is the integration phase where the patient works with the lead therapist to process the deep insights that are typically generated through a psilocybin therapy session, the therapy process, a similar way to act acceptance and commitment therapy and a method of levels.
[00:20:53] So we're very much a mindfulness-based therapy approach, and it's very interesting the, uh, the patients, um, as they're going through psilocybin therapy often feel like they processed a lot of deep rooted psychological issues. Um, when we look at, uh, at the data from the academic trials and some of the open label trials would be, what we often hear is while this therapy felt like 20 years of psychotherapy condensed into six hours.
[00:21:15] For the first time I had immediate insight into my suffering. I finally understood why I became depressed. I see a clear path forward, and that is again, why it's important that, um, the therapists are very much focused on getting the integration piece, right.
[00:21:27] Greg Kubin: So you have a few sessions with the therapist, then you have the psilocybin therapy experience.
[00:21:32] Then you have a few more integration sessions. What I haven't fully resolved in my own mind is this idea that maybe the patient is, has treated their treatment resistant depression, but there's still a lot more work to do. Right. That thing that came up that caused their depression actually was something really deep, really powerful thing.
[00:21:54] So where do you see the role of the patient after they've completed the protocol to check in with a therapist? Is it something that they're then responsible to on their own? How do you think about that?
[00:22:07] Lars Wilde: Yeah, that's a great question. Obviously, there are the limitations of running clinical trials. Um, so we can't introduce too much of a variability from patient to patient.
[00:22:15] The patient can access integration therapy, integration sessions are based on need. Um, so some patients might be finding one sessions. Other was two other was three, depending on what came up during the session. That's a clinical trial, right? And then we're following these patients until the primary end point after three weeks.
[00:22:30] And the second year, the secondary end points after 12 weeks, I think, um, what's probably more relevant is how is that going to unfold that in the real world? And as he said, right, I don't believe it's a cure and life happens to all of us, right. Even if you improve in the very moment, you process something, something else might happen to you and you might become depressed again.
[00:22:47] Or you go back to an environment. Situation of learned helplessness or retraumatization event. And you're back to where you started. Right? I think these, these things have been seen in some of the MDMA trials have been seen in the psilocybin trials. Um, it's, it's not a magic bullet. And I think that's why we, we caution everyone that this will likely be an intermittent treatment, um, that patients will be able to access on a need basis.
[00:23:08] As you say, some patients might be able to work through their baggage within one session. Others might need more. And then again, it's really important as you said, the integration part, right? You might learn things about your past, about your own behaviors that we need quite some time to integrate. I think that that is the role of therapy, uh, to then work with the patients.
[00:23:25] Makes sense of this experience, um, integrate this appropriately. And I think I would say that what is very encouraging, what we're seeing in one of the programs that we involved in with, uh, patients that suffer with a major depressive depression diagnosis due to their Kansas suffering, is that in that study in Maryland, um, patients are prepared, treated and integrated in groups of four.
[00:23:46] And these patients form very strong bond over this experience and networks are formed out of the sort of groups that want to stay together. They want to stay connected. They exchanging their experience with each other. And I think that could be a role going forward. That indeed, when you think about how a psychedelic therapy going to scale up in the real world, Um, that this could be moved much more into a simultaneous administration model of where patients are going through these experiences together and groups can form that then can integrate together and have this kind of accountability, uh, repre I would say to the therapy.
[00:24:16] Matias Serebrinsky: It's interesting that. You know, explaining these one thing that comes to mind is how heterogeneous the treatment could be group therapy, individual therapy, you know, multiple sessions, one session. I want to go deeper into how you decide that the protocol let's start with dosage. There's this term in psychedelia, that is the heroic dose.
[00:24:40] Uh, but there's also the high dose, the low dose, the microdose. How do you think about which dose to use for your treatment?
[00:24:47] Lars Wilde: Yeah. And that is a very important question. Right. And, um, so we have three arms our phase 2B program. Uh, we treated a total of 230 patients, uh, in that study. And, um, they were randomized to either a one milligram, a 10 milligram or 20.
[00:25:03] Uh, milligram dose the month, one milligram is basically an active control group. It does not have any psychoactive effects. Then there's a 10 milligram dose, which is a medium intense psychedelic experience. And the 25 milligram dose is a high dose experience. And we've picked that dose based on the work both in the late 1950s and 1960s.
[00:25:21] And then over the past 20 years with psilocybin, it has been shown that this dose range seems to most reliably lead to improvement in a whole variety of disorders. We now begin to understand why that might be. Um, so it seems to very reliably at the 25 milligram dose, the patients, uh, go into a transcendental state, which when we look at the neuro correlate, what does that mean in terms of what's going on in the brain?
[00:25:43] We see that there's a disintegration of network connectivity in the brain predominantly. Uh, specifically the default mode network, which constitutes our sense of self a network. That's very much implicated in when we're thinking about our past or when we're planning for the future and what psychology science has shown us that there's an unhealthy over strengthening and that network connectivity and patients that suffer with affective disorders so often represented by rheumatory thinking patterns learned helplessness and negative attention.
[00:26:08] Right. And so this integration of that network seems to lead to a normalization of thinking patterns paired with strong increases in neuroplasticity and strong decreases in neuro inflammation. And therefore that seems to be that the 25 milligram dose very reliably resides in this state. Now at the moment, I would say this is still at the hypothesis stage.
[00:26:25] Um, so we're going to know. Very concretely, uh, later this year, once we unblind the data, if that is too, um, if we're going to see the difference between the one 10 and 25 milligram dose, but I'll hypothesis that the 25 milligram dose with the dose that we take forward into the phase three program.
[00:26:40] Greg Kubin: about the fact that certain people have different weights?
[00:26:44] How do you control for that?
[00:26:46] Lars Wilde: Yeah, that is interesting is this seems to be largely the band. So we've seen that most academic trials as well are moving to a fixed dose regime. There are indeed some biological factors that might influence the distribution of the drug, but that doesn't seem to be body weight. Blood volume, for example, could be a contributing factor.
[00:27:01] But therefore I think with a 25 milligram dose, that seems to be sufficiently higher at least in depression related and anxiety related disorders to reliably lead to a high-dose experience as measured by for example, a mystical experience, scale, or share any boundaries in escape as a proxy for the downregulation of the default mode network.
[00:27:17] And when we look at it from running a clinical trial, you want to standardize where you can and, uh, doses is one such thing.
[00:27:23] Greg Kubin: One other question about the product, which is called comp 360, do patients or anyone else who has tried it, employees report any differences between that experience and the actual psilocybin mushroom experience?
[00:27:40] Lars Wilde: Yeah, that is an interesting one. I think I can point you to is the phase one program that we ran, where we looked at the subjective reported effects on the 10 and the 25 milligram dose. And they were consistent with the experiences that patients had in patients and volunteers. Psilocybin studies now in the clinical program, uh, we're limiting the amount of patients that can have had prior to psychedelic experiences to 10%.
[00:28:03] So most patients wouldn't be able to compare between a recreational dose and psilocybin. Now, I would say just looking at, you know, at the molecule psilocybin. So listen, at least it's the main psychoactive component in magic mushrooms. I think there's this nice anecdote where Albert Hoffman, when he synthesized psilocybin for Sandoz in 1950s, Uh, when he went to Mexico, when shared appeal with this, uh, psilocybin with Maria Sabina, uh, the curandera that was, um, introducing the Western world to magic mushrooms
[00:28:33] and she confirmed to him that his pill contained the spirit of the mushroom. Now, I don't know how good an evidence that is, but, uh, what we do know is that indeed, uh, psilocybin leads, uh, in these academic studies. And now these clinically regulated studies, uh, to the beneficial outcomes. And that is really what, what matters to us.
[00:28:51] Greg Kubin: So if you're, you have three different groups in your study and the control group is one milligram, there is a body of evidence that demonstrates that a microdose still has the neuroplastic neurogenesis benefits. And so what we were talking about was whether that would potentially create positive outcomes for people with TRD.
[00:29:12] But I think that's the purpose of the clinical trial. Maybe it will. It was just kind of thinking through the trial design of why one milligram. And if you think there's that chance that some people would actually benefit from it. Yeah.
[00:29:24] Lars Wilde: Yeah, that is a very relevant question that why the one milligram dose and, and the idea of the choice of the one milligram dose was actually, how do you go about blinding in such a study?
[00:29:33] Right? Because the likelihood of functional unbinding is, uh, is very high as said, we're recruiting largely the, if patients that you've to the psychedelic experience into that study and all these patients know that they will receive an active dose of psilocybin. So what that allowed us is to manage the expectancy.
[00:29:49] But again, it's likely to functional unblinding when you're in the 25 milligram arm is very large. So how do we remain the blind in the study is by actually deploying fully independent raters that are blinded to the study design and the nature of the study drug in the clinical trial. And they are then assessing the patient's depression state over time at the various time points.
[00:30:09] And so they're not part of the therapist staff that might have observed the actual therapy session. So that's very important now with the one that there's still this raging debate, I would say on, you know, does dosing do something? Does it work? You know, even if it does, I think that it would have a dose dependent effect, right.
[00:30:23] And probably you would have to dose it over time. And so we don't expect the one milligram dose to have any meaningful anti-depressant effects and I think when you look at the literature, what science has shown thus far, that seems to be consistent. I would say, for example, I was interesting in Robin Carhartt-Harris's study in a major depressive disorder where he compared Escitalopram and therapy to psilocybin therapy, where eventually he showed that psilocybin therapies non-inferior to Escitalopram, the Escitalopram actually also got to one milligram doses.
[00:30:49] And what's interesting in that study is that despite the small size with only 57 participants, interestingly psilocybin on every single measure, at least numerically outperformed Escitalopram plus the one milligram dose. So we're very comfortable that, we won't see any major effect from the one milligram, dose especially not a long enough one.
[00:31:05] And therefore, you know, I would say that also the choice of the primary end point would solve that issue in that, you know, even if there's a modulator on the day effect from the one milligram dose that should very quickly. Uh, we're actually for regulatory purposes assessing the depression state at week three.
[00:31:18] And so our expectation is that until then, what are we going to see is purely the drug effect and the assumption that the high dose will clearly, uh,separate.
[00:31:25] Greg Kubin: So I have two more questions about the trial slash therapy, and then we'll get to the business side. Matias, I know you're, you're itching to get to that.
[00:31:32] So one is a quick question. One's a medium question. So one question you had mentioned the primary endpoint, and I feel like this could be a good opportunity for our listeners to kind of talk about in clinical trial design, how there are primary end points, secondary end points, and what primary end point you chose and how you measure it.
[00:31:51] And basically how it's judged.
[00:31:53] Lars Wilde: Basically in your statistical plan, you stipulate what you're actually trying to answer scientifically in your study and dependent on that you pick end points where you take measurements. In our case, the depression state of the patient in our study, we're assessing the depression state by the Montgomery expert, depression ratings.
[00:32:10] Um, that's a questionnaire that's administered by again, the blinded and independent rater that at the various time points, uh, engages with the patient to understand where they are in the mental health journey. And the primary end point is really relevant to say, does the treatment work or doesn't it work?
[00:32:24] And then the secondary end points are answering more scientific questions, especially as they relate in our case to the durability of the effects as we're assessing the primary endpoint at week three. And then we're following the patients for another nine weeks to week 12, where for example, Looking at the proportion of responders that maintained an improvement in the depression greater than 50% in order to understand, you know, how good is that treatment over time for whom does it work for prolonged periods of time for whom doesn't it work?
[00:32:49] And that will then also influence the design of both the phase three studies and some of the more, let's say mechanistic studies to answer, you know, if somebody did not respond or did respond really well at week three, but then relapse into the depression that we 12, what do we learn about this patient?
[00:33:02] Could that patient have been helped by another session? At week six, for example, how would we design a study to answer that question? So it's very important for us to look at both of these end points, the critical one, obviously being the primary end point that will allow us to then progress into the phase three, both in North America and Europe.
[00:33:17] Greg Kubin: Got it. Okay. My last question, how many people are signing up for your trials?
[00:33:21] Lars Wilde: Yeah, depends on what trials you look at. And so we were involved in a lot of signal generating studies in various indications, and we see huge demand for that. I think, uh, what I can say by now is that we recruited extremely rapidly into our treatment resistant depression, regulatory trial as well.
[00:33:37] Despite a break that we had due to the COVID center. And, um, unfortunately notoriously these treatment resistant oppressions are very poor ritual to us because there's very little interest typically by patients, they have exhausted all kinds of treatments already, and you hear things like, oh, I don't need another pill.
[00:33:49] Nothing has worked for me anyhow. And so we see that there's much more excitement around psilocybin therapy. Now that also comes with a couple of problems. You want to make sure you recruit the right patients into the studies. I think that's a that's that's crucially important. And many depression trials have failed because they didn't recruit the right patients.
[00:34:06] So patients that had other disorders and said like, oh, I want to try this. Maybe this also works on depression. And so we prevent that by having actually physicians refer the patients into the study. So we're working with local psychiatrists and GPs that are referring their treatment resistant depression patients into the study with the patient histories that we actually understand their patient journey.
[00:34:23] We understand what drugs they have been on if they actually fulfill the entry criteria and also the exclusion criteria. So for example, in the study, we are excluding patients with a family history of schizophrenia or prior episodes of psychosis, borderline syndrome, and a few other exclusion criteria. And that makes you aware that we have the right patient enrolled in the program.
[00:34:40] Makes sense.
[00:34:42] Greg Kubin: Uh, okay. Business, Matias. Why don't you kick off the business side of this conversation?
[00:34:47] Matias Serebrinsky: Let's talk business. So I want to start by. Breaking down your model. And one interesting thing about it is that it is not just a pill, right? And so it includes components of biotech company, but also components of a healthcare company, so to speak.
[00:35:04] And so I would love for you to break down how you think about the model, what it means to be vertically integrated, what your centers of excellence are.
[00:35:15] Lars Wilde: Yeah, I think you're making a very important point, right? What's going to get approved eventually. It's not a small molecule, but the therapy and everything that comes with it, right.
[00:35:21] Including the training of the therapist, qualification of the therapist, the extra administration of the therapist, and to any, to support towards. And that is what you actually have to develop through the clinical trials. And that is, that would eventually gets approved. Then obviously the question is, how do you scale this?
[00:35:35] And, um, it's a part of our business at the moment is setting up, uh, centers of excellence with leading academic or commercial partners. You know, those are basically psychiatric clinics of the future. How we envision psychedelic therapy should be brought to the world in these centers where training therapists were running a signal generating clinical trials or we're training therapists.
[00:35:52] And we have a place where we can actually then take entrepreneurs that are setting up psychedelic treatment centers and you mental health care clinics, as well as, uh, insurances that can come there and see how this treatment would be delivered in the future. And, um, yeah, uh, a business model is really developing a site of some therapy and other psychedelic therapies in various disorders.
[00:36:13] Beginning with treatment resistant, depression, other depression disorders, but then also going broader. So we're exploring a psilocybin as well in eating disorders and obsessive compulsive disorders, including for example, a body dysmorphic disorder and suicidal ideation in anorexia, in chronic cluster headaches and PTSD in order to understand which patients could really be served by this treatment.
[00:36:34] Then once we understand that we get a good signal in any of these patient populations, then the goal is to. Drive these programs very quickly, uh, through phase two, B and phase three studies all the way to approval. I think that is something that I would want to highlight. So we don't understand ourselves as a biotech company, biotech as part of what we do in pharma as well.
[00:36:51] But we understand ourselves as a mental health care company. So we're always keeping the patient in mind. We have patients on our advisory board and scientific advisory boards and, um, oligos to actually commercialize, um, psilocybin therapy and actually bring it to the world and really work deeply with healthcare systems to make sure that people can get access to this therapy.
[00:37:09] Greg Kubin: So as part of the idea that if you get approved for TRD treatment resistant depression, with your COMP 360, the synthetic psilocybin, you will be better positioned to get approved for other indications. So it's just the ones you just mentioned using the same COMP 360, because you have already gotten approval in the earlier stage clinical trials from the health and safety side of things.
[00:37:36] You don't need to go through that again. You can just apply that to other indications.
[00:37:41] Is that right?
[00:37:42] Lars Wilde: That's a very good point. Yeah. I think there are clear synergies because it can use the same data package in terms of all the toxicology work and the CMC work, et cetera. So, so that is absolutely true. But then again, every disorder is different.
[00:37:54] So the therapy model might vary. I think we're where we find another synergies in just running late stage clinical trial. So. And the phase two B program, we had 22 clinical trial sites in 10 countries. And you need to get the approvals. You need to make sure where everyone and every part of the supply chain is adequately licensed with the drug enforcement agencies so that he can actually get drug product to the sites and that people are allowed to deal with a schedule, one drug.
[00:38:16] And we're scaling that up now in preparation of phase three. So we're going to have between 90 and a hundred sites in the phase three program. And so we're going to be operating the largest infrastructure to really run stage 3 clinical trials and that it would be our focus going forward. And we are entertaining discussions with other companies in early stage and pre-clinical development of novel treatments that do not want to undertake that part of the business.
[00:38:37] So they don't want to be a multinational direct development company. And I think that is the role that we want to play. Part of driving these late stage clinical trials all the way to approval and then making sure that we actually commercialize. And when we say that, um, the focus here really on the both distribution and reimbursement again, it's something that I keep highlighting.
[00:38:55] Uh, without reimbursement psychedelic therapy will not happen at scale.
[00:38:59] Greg Kubin: Let's talk about that. So what do you project to be the cost of your treatment and what needs to be proved to insurance companies for them to actually cover these treatments?
[00:39:08] Lars Wilde: Yeah, that's a complex answer. I think, uh, the easy answer is cost effectiveness.
[00:39:13] Um, but then every system has their own way to define that. And, uh, basically what the system looks at is what does a patient cost me today with the administration of a new therapy? Can I reduce that? Some systems also looking at, can I improve that quality of life of that patient? Even if the cost to me is higher.
[00:39:29] And so you have to go see this actually country by country. So there was a big part of our work over the last three years to work with all European countries and their HTA bodies to understand what data do we need to generate so that they will actually be able to not only improve psilocybin therapy, but then also reimburse it later.
[00:39:45] And the answer will lie partly in our phase two B program already. After that we will understand how many patients do really respond, uh, remits and when do they relapse. Um, and that will then answer the economic modeling question of how often do you have to deliver psilocybin therapy to a patient. And then you compare that to the cost of the patient, to the system today.
[00:40:03] And therefore we're deeply thinking about scalability of this treatment. Right? I spoke about some attendance administration in the phase one program we've given psilocybin therapy to up to six participants at the same time. We're now seeing that under R I N D psilocybin can be given to four patients at the same time they can prepare and integrate together.
[00:40:20] And that will inform us well, how we think about how to escape this therapy in the long run,
[00:40:25] Matias Serebrinsky: I went to go back to Greg's question about COMP 360, potentially being extended to other indications. And I will wear my investor hat, my early stage investor hat for a minute and ask for your help. What does it mean for
[00:40:42] either companies that are developing psilocybin therapies or companies targeting TRD with other psychedelic therapy.
[00:40:51] Lars Wilde: Yeah. So let us tackle the other psychedelic question first, because that's easy. So if somebody develops a different treatment, uh, for a given indication that can come to market, what they need to show is that the treatment is efficacious.
[00:41:03] And I think in terms of reimbursement, they need to show in most countries, at least non-inferiority. Uh, so they need to show that it works equally well, like psilocybin therapy in that indication in some countries, they might even have to show superiority for reimbursement. Now the second question is more complex to answer.
[00:41:18] So if somebody else develops psilocybin for any indication, so first of all, I think, yeah. Let's take it. If someone doesn't develop it. So generic competition, so generic competition will not be able to enter the market for at least seven and a half years in the United States. And up to 11 years in Europe, based on the regulatory exclusivity once COMP 360 psilocybin therapy gets approved.
[00:41:40] Now, then there might be other companies developing psilocybin, really through clinical trials all the way. And then it depends much more on our patent position for what we're developing, which includes our specific polymorphic form of crystalline psilocybin. The way to synthesize that specific polymorphic form, the use of that polymorphic form in the indications that we're tackling.
[00:41:59] So if somebody would take the same polymorphic form and develop. For any other indication that would still infringe on our patent position. Somebody picks another polymorphic form if that exists and they would develop that polymorphic form and they could absolutely come to market.
[00:42:13] Matias Serebrinsky: What if it is not a specific, uh, polymorphic form, but it's a generic psilocybin.
[00:42:21] Lars Wilde: Now that becomes a difficult question to answer, because then we don't know what is in their psilocybin. So any solid form will be some type of polymorph. And the question is, you know, would that drug product contain our polymorph it wouldn't it, if it would contain our polymorph, they would infringe on our IP.
[00:42:37] If it does not contain our polymorph, they would not. I think you shouldn't underestimate what it takes to develop a psychedelic therapy all the way to people. Both in terms of just sheer effort, but then also in terms of capita, right? Developing psilocybin for any given indication would cost somewhere between three to 500 million in capital that needs to be raised and, and adequately spend.
[00:42:56] Uh, so it's a huge task. And I think, um, doing that creates another barrier of entry for any, any also runs.
[00:43:02] Matias Serebrinsky: That is a great segue to keep my investor hat on. Ask you another question, which is you guys were really good at fundraising. What is the secret?
[00:43:13] Lars Wilde: Yeah, I think this, well, I don't think it's a secret. I think it's, um, the recognition of investors that this is a huge issue and that there is a potential solution for that huge issue.
[00:43:21] And then it's all about getting in front of enough people that buy into that vision and can understand that this might actually work. I think that we did well, uh, to, to convey kind of the state of the research and the nature of the problem. And also that it's a growing problem, right. To, I think, uh, you know, we always talk about the COVID pandemic.
[00:43:38] I think that's a mental health pandemic with constantly rising numbers. And people are very well aware of that. And you now see not only a psychedelic science Renaissance, I would say, but you see a real Renaissance in mental health research, and that is something that maybe your listeners might not be so aware of.
[00:43:54] But when you look at the average pharma company that was running trials in psychiatry, Uh, the psychiatric drug development typically set in their neuroscience divisions. Now what pharma has done over the last 25 years was a very strong focus on Alzheimer's and dementia following the Amyloid-β and tau tanglement hypothesis, and they put over a trillion dollars into Alzheimer trials, and none has worked.
[00:44:16] I mean, there's obviously a, you might be aware of this huge debate, uh, by the FDA approving a drug recently, which I feel has a good chance of being pulled again. And so they wasted a lot of capital there. And so many pharma companies actually said, look, we're not going to do anything in neuroscience anymore.
[00:44:30] They still with their franchises or they close their franchises. And with that, oftentimes they also killed their psychiatry franchise. It's not without pharma being available. Uh, biotech, it didn't get started because it didn't have real ex of channels. And, um, so it has to be real drought over the last 15 years in psychiatric drug development.
[00:44:47] And I think J&J was the first company that really, really changed this, uh, with being able to show them. We're able to get as esketamine at one of the isomers esketamine approved in psychiatry. And I think that was a, you know, that goes back to the question of why now, right? People suddenly saw the FDA is open to approve a depending on who you talk to a psychedelic drug, or at least a dissociative drug hallucinogen for people suffering with depression.
[00:45:09] Then we had a much better understanding of why psychedelics might work. We had the great body of evidence from academic trials. You know, also have this huge burden of depression. The world health organization made the world aware that depression is the biggest disease area that as humanity is facing.
[00:45:24] And then, uh, I would also point out Michael Pollan who you might know the science author that put out the book, how to change your mind, summarizing the state of the research. And initially it was quite difficult to convince investors that psilocybin therapy had merit. And, you know, we, we could get a couple of very contrarian investors like Peter Thiel, um, involved and Christian Angermayer and Mike Novogratz that are always investing at the frontier, but then they're obviously much more conservative investors out there with very deep pockets and they stayed much more on the sideline.
[00:45:52] But actually, when we went out to a race, a lot, a financing round people had begun Michael Pollan's book, and that also changed the attitude and they realized, oh, this is real. This is not some bunch of hippies coming together and faking it in clinical trials. But they realized, oh, there's merit breaking adversities is actually doing this work and great researchers are coming into this field.
[00:46:10] I think that altogether made it much easier for us to then raise the funding for the company.
[00:46:16] Matias Serebrinsky: Because there were no acquires for emerging biotechs. There was less innovation coming in psychiatric disorders. So one interesting reflection there is that now that we have companies like Compass or atai in the market that might actually.
[00:46:32] Create more opportunities for small companies to innovate and have an opportunity to be acquired. So these new, bigger companies emerging in the psychedelic medicine space will actually create more innovation from smaller companies in the future.
[00:46:47] Lars Wilde: That is a super important point. And I think it's not only psychedelics, right?
[00:46:50] I think, you know, psychedelic is a treatment in mental health, like many other treatments, and there will be other great treatments that are going to be developed over the next 10, 20 years. And, you know, I would just point to the recent acquisition of GW pharma, which was focused on cannabis, derived drugs, mostly CBD and THC developed for MS and epilepsy, they were acquired for 7 billion by jazz pharmaceuticals. And Jazz is another player in the mental health space and urology space. They actually brought the first probably drug that you can kind of remotely put into the category, of psychedelic or empathogen to market GHB, which is another regulated drug.
[00:47:24] They brought it to market for narcolepsy. They now acquired the cannabis franchise from GW pharma, forming a giant in the fields. And you see many other companies coming back into psychiatry, J and J obviously with the sprovata program. So indeed people are recognizing the need, but also the opportunity of better understanding of the brain.
[00:47:40] And that's what it goes back to. Right? Once we understand human suffering, how that translate into a brain mechanism, then you can create great treatments. And I think we're just at the beginning of that.
[00:47:49] Greg Kubin: One other topic that we haven't fully addressed. You touched on at large, but I want to talk about the thinking behind the Compass patent strategy feels like a topic that we need to cover because it's, uh, it comes up.
[00:48:02] People definitely have addressed some skepticism towards it being a bit over arching in terms of some of the specificities, um, people in particular. Go gravitate towards the idea of holding hands with the therapist being covered or the soft couch.
[00:48:21] Lars Wilde: Yeah. Patent law is complex. I think there's a lot of misunderstanding out there.
[00:48:26] So I think first off, I would say that, you know, the rules of patent law are pretty clear. You can only patent something that's novel and inventive and yeah. So anything that's out there is not patentable. Now you can recombine known things into something new, which might become then patentable again. And I think, you know, when you look at our IP and granted patents, what you see is that everything that was granted was based on innovation that we have created be it the synthesis be the polymorph the routes of administration of formulation, et cetera.
[00:48:52] Now the patents have been heavily challenged. Yeah. As you said, both, uh, in the press, uh, or in the psychedelic community and also by, uh, competitors that attack the patents pre grant and, um, sued us post grant or presented us with a post-grad challenge in the United States and in the UK. That was a very interesting, is that the us patent office reviewed the challenge and they looked at what we did and they agreed that indeed our work with novel and inventive had not been disclosed in the prior art.
[00:49:19] And so we had all the right to patent what we patented. Now people can like that or not like that, but I think this is what you need to do, right? If we do not protect what we are a newly created, and then there won't be a business in the future, because then the issue running into is that any other company can also start selling our drug product and run our therapy
[00:49:37] post-approval so, um, obviously we have a very strong focus on protecting will work. Now you mentioned the treatment rooms, wall colors. If you read it. Before that in the patterns we're seeing that we're treating humans. That doesn't mean that we're patenting humans. Um, and I think, you know, I've, I've come on a record and said, look, we're not patenting a set and setting.
[00:49:56] That is not our objective. What we felt is what needed to be done is to describe the safe container in which COMP 360 should be delivered. We firmly believe that for patients, they should be a certain container in which, uh, that treatment should be delivered, including how the therapist interact with the patient, how the room should look like that is not to say that if somebody else develops another psychedelic and another treatment, that they couldn't do it in a nice looking room with a sofa in it that has been misconstrued in some of the reports.
[00:50:22] Greg Kubin: Got it. So what you're saying is the patents, I guess, are describing your process and your way of going about it. And that kind of is why certain specific components, like the color of the wallpaper are included, but that's not the part that necessarily. What you're looking to enforce. It's more the focus on the composition of matter of the COMP 360 and the specific protocol of pairing your form of psychotherapy with that
[00:50:52] Lars Wilde: That is correct. You know, and, and many other things that are covered in these patents, such as digital tools and method of use, et cetera. And I think what I would say is that these a PCT files.
[00:51:02] Greg Kubin: Lars, you touched on technology being part of your therapeutic process. I've heard you talk about digital phenotyping and it would be really awesome to hear about what is digital phenotyping and how you see that integrating into the experience for the patient.
[00:51:16] Yeah. So
[00:51:17] Lars Wilde: it's an interesting process. Actually, we're building a very large technology team at the moment around the team, um, that has been working on that over the past periods. And there are a couple of objectives there. Some, some things that have been built already, such as a scalable, uh, therapist training platform.
[00:51:33] So we have an educational platform to train. Therapists and the theory and some practical aspects of psychedelic therapy before they don't engage in in-person training. And I'm actually sitting in sessions with patients. We've also built a patient preparation platform so that the patients have time to engage with the preparation process at their own time outside of the in-person preparation.
[00:51:52] But then we're looking at, you know, how can you incorporate digital therapeutics into the mix? And you mentioned one of such tools such as digital phenotyping. So already in our phase two B program, we're deploying a digital phenotyping solution because what'd you see in the studies that have been done today, does that, uh, depending on what side you look like between 50 and 90% of patients respond really well to psychedelic therapy, but then you see the durability of the positive treatment effects vary widely across subjects.
[00:52:16] For example, in Robin Carhartt-Harris' study, there was a 90% response rate in the study. There was a great response in all patients that responded until week three. And then you saw some worsening in some patients and other patients didn't go back on any antidepressant until the last measurement, which was at six months, I believe in that study.
[00:52:33] And anecdotally people did not go back then after. Now that is interesting because ideally you wouldn't want to let the patients become depressed again, but you would want to catch them early. And the question is, how do you catch them early? And what has been shown in science is that typically your partner that you live with sees that you're becoming depressed before you yourself actually recognized that you're becoming depressed.
[00:52:53] And that can be 10 to 14 days before the patient, him or herself realizes that they are depressed again. So there's this worsening period of symptoms, um, that are observable to the outside world. And the theory is that you might pick up on these behavioral changes by looking at, for example, mobile phone use and do that passively.
[00:53:11] So we, you know, we all have the supercomputer in our pockets, which is all mobile phone, iPhone or Android. And we engage with it all the time. Right. We are walking around with it, so it knows how much we move. We switch it off in the evenings when we go to bed and we pick it up first thing in the morning.
[00:53:24] So this thing also knows how much we have slept. You know, if you have interrupted sleep, which is a predictor of depression, you know, we didn't understand whether you're in the proximity of other people or not. And your acceleration, whether you do sports, et cetera. So there are many pieces of information that mobile phones can can track.
[00:53:38] And I think the interesting bit here is. Patients, uh, before, uh, going into psychedelic therapy, they are in our case depressed. And so based on their mobile phone use, we know how they behave when they are depressed. Now we treat them and afterwards, if they do respond favorably and they're out of their depression, we would hope that they have a different behavioral profile that.
[00:53:55] Trackable via the mobile phone use. And then we have this two phenotypically expression off of themselves. So ones when they are depressed, depressed, and once when they are healthy, now we can see if these different profiles converged all the time. And if we observe that convergence, we might infer that that patient is slipping again.
[00:54:11] And so we can then alert the patient, say we, uh, we observed that your depression state is worsening and we would recommend you have another psilocybin session. Now, does that fit into the overall business model? When you look at the innovative payment models with payer systems, um, you see that there's something called outcomes based reimbursement or risk share models, where you say, look, we take over the management of the patient.
[00:54:29] We guarantee that we can treat the patient adequately and only if we are able to do so, we will be paid for it. And so in depression, we know that whenever a patient becomes depressed, again, the chance of that patient recovering out of that depressive episode decreases and therefore the kind of holy grail and depression care would be to prevent people from becoming depressed.
[00:54:46] Again. And so hopefully in the long run, we will be able to build such a solution that will allow us to predict a patient's depressive or mental health state, and then prevent them from becoming depressed again.
[00:54:56] Matias Serebrinsky: I want to do a couple of rapid fire questions before we leave. The first one is what is often misunderstood about compass pathways?
[00:55:07] Lars Wilde: I think I said that we are a mental health care company and our vision is to create a world of mental wellbeing. Um, I think we are often reduced to, oh, you're just another biotech. And, uh, I think that couldn't be further from the truth.
[00:55:19] Matias Serebrinsky: The second question is what are your thoughts on security companies that do not offer therapy as part of their clinical trials?
[00:55:27] Lars Wilde: It's irresponsible and shouldn't be allowed.
[00:55:30] Matias Serebrinsky: What is your view on Oregon's psilocybin therapy measure 1 0 9.
[00:55:35] Lars Wilde: Yeah. I mean, this is a really strong vote of confidence, right? I was blown away by how many people got behind psilocybin therapy in Oregon. And I think it's just a testimony of the need that's out there.
[00:55:45] And I think this is something that we're going to see across the world where patients are waking up to the promise of psilocybin therapy and other psychedelic treatment.
[00:55:53] Greg Kubin: My quick, rapid fire question is, is your job stressful?
[00:55:56] Lars Wilde: Uh, which, which job isn't stressful and I think, uh, positive stress, right? I think it's such an amazing thing to be working on.
[00:56:02] I don't perceive that as negative stress. Um, it's a lot of work, uh, but it's great work.
[00:56:06] Matias Serebrinsky: That's a good answer. Lars, can you paint the picture of what the psychedelic landscape will look like in 10 years?
[00:56:13] Lars Wilde: Yeah, happy to. I think I would discriminate between, you know, psychedelic or, or mental health. I think for us, it's saying no compass is all about mental health care.
[00:56:19] Um, so I believe that psychedelic therapies would have played a huge role in mental health care. And I think that a great start has been made by ketamine Esketamine. MDMA now with a successful phase three program, hopefully on market within the next two years, psilocybin therapy on market 24, 25. Um, and I think then a broadening out into other indications.
[00:56:40] And so what are we going to see as an explosion of treatment centers? Uh, you know, and now every. Medium-sized city in the United States has a ketamine treatment center. Um, these are morphing into psychedelic, uh, or integrated mental health centers at the moment. And I, I believe, you know, when we, when we fast forward, every little village will have such a center within the next 10 years that we'll be administering these treatments to patients.
[00:57:04] I think eventually we will move into a world where these will be used as preventative treatments. Where we actually don't wait for people to start suffering, but we are aware that there's a strong interplay between psychology and psychiatry and you wouldn't want to wait. And so I believe that, uh, indeed, within the next, uh, 10 years, we will have ubiquitous access to psychedelic therapies for patients that are suffering.
[00:57:28] And, uh, to answer your wider question Matias, the thing in terms of the psychedelic landscape I think we will have, at least in the Western world, the widespread decriminalization of psychedelic therapies or psychedelic experiences for, for people that are not on the, let's say mental suffering end of the spectrum, but that want to work on themselves for other purposes.
[00:57:50] And so I see a strong interplay between these and I think eventually these centers would merge into, into one type of entity.
[00:58:03] Greg Kubin: This is Business Trip, a podcast about psychedelic entrepreneurship. If you liked this episode, you can help us by subscribing to the podcast and leaving a review. You can tweet at us or find us on the gram at businesstripFM. And if you're building a company in psychedelics or looking to get more involved in this space, email me at firstname.lastname@example.org.
[00:58:24] This episode was co-hosted by myself, Greg Kubin and Matias Serebrinsky. Producer and editor is Jonathan Davis. Sound design and engineering came from Zach Frank. Our theme music is by Dorian Love and additional music credits are in the show notes. This is Business Trip. Thanks for tripping with us. We'll see you next time.
[00:58:52] Matias Serebrinsky: Let's talk. It's taught. It's taught business. It's taught
[00:59:02] Greg Kubin: Matias and I are co interviewing. We like chatting with each other, chatting with each other, each other. It's not just one of us, but. Two of us, two of two of us. It's kind of fun. We compliment each other. Well, we also have been investing in this state.
[00:59:21] Matias Serebrinsky: I will wear my investor hat, my investor hat on, ask you rapid fire questions, rapid fire question, rapid fire, rapid fire, rapid fire question, question,
[00:59:33] Greg Kubin: and answer, answer.
[00:59:35] I'd also add to that, that, that
[00:59:37] Matias Serebrinsky: we kind of