Maybe it's okay. All right. Let's get started. Good morning, everyone. I'm David Hoang. I'm the Senior U.S. Biotech Analyst here at Deutsche Bank. I'd like to welcome everyone to the second day of our second annual DB Healthcare Summit. With us here, we have COMPASS Pathways for our fireside chat. COMPASS is a pioneer in the field of psychedelic medicine with its psilocybin therapy, COMP360, on track to becoming the first classic psychedelic to potentially reach the market in 2027. I'm joined by Lori Englebert, Chief Commercial Officer, Teri Loxam, Chief Financial Officer, and Dr. Steve Levine, Chief Patient Officer. Thanks to you all for joining us. I'll pass it over to the COMPASS team for some introductory remarks to help level set everyone, and for those in the audience who may be less familiar with the COMPASS story before we dive into Q&A.
You want me to start? We're going to be passing it back and forth throughout today. Thanks for having us, first of all. Really appreciate being here. We'll likely be providing some forward-looking remarks, because our lawyers are always interested, check our risk factors. We are, as David mentioned, in the lead in terms of psychedelics, potentially getting to market. We're in really, really good shape. We've completed two phase III trials, both being highly statistically significant. Really great results and a really incredible profile that Lori can talk more about as to why we feel like COMP360 is so differentiated. First indication is for treatment-resistant depression. We are also underway with a late-stage trial in PTSD, which will be a follow-on to TRD. We are in a rolling submission and review right now with the FDA for our TRD product.
We anticipate completing that submission in the fourth quarter, and we have guidance out there that we expect to launch within the first half of next year. We are really on the doorstep here of bringing our synthetic psilocybin product to market, and really excited by the progress. We have made tremendous progress, not only from a clinical development perspective, but also on the commercial side. The only product right now that's out there approved for TRD is SPRAVATO, which is a Johnson & Johnson product, and we are able to leverage a lot, if not all, of the work that they have done in launching their product, for COMP360. Both Lori and Steve can talk more about that. We're in really, really good shape. Really excited to bring this product to market.
Great. Well, thank you for that. Maybe to begin, could you walk us through the sequence of events going from the completion of the NDA filing for COMP360, which I believe is expected to occur in Q4, from there to potential commercial launch in the first half of 2027, as you have talked about. Really what are your estimates, I guess, at this time in terms of FDA review, DEA rescheduling, and state rescheduling?
I'll take that one.
You want to take that?
Yeah. I'll take that one. We spend a lot of time together, so probably going to be figuring out who wants to answer which question each time. Right now, as we've previously stated, we intend to complete our NDA filing in Q4. Just to level set, in 2018, we received Breakthrough Therapy designation. But most recently, in April of this year, we received the commissioner's Priority Review Voucher, and we also will potentially benefit from the Executive Order on DEA. We also had an agreement with the FDA prior to receiving the voucher to undergo a rolling submission and rolling review. This is something that the psychiatry division, to our knowledge, has not done, at least in the recent history. We would have been the first product to benefit from a rolling review. Then we received a Priority Review Voucher, which did two things.
What that did is it increased the frequency of conversation with the FDA, and it also allowed the FDA to have a target review time of one to two months. Once we complete the NDA filing in Q4 of this year, what we anticipate is a little bit of uncertainty in terms of timing of approval, because the FDA does clearly state a target of one to two months. We do not know if they will take the 60 days to do an acceptance period and then the target one to two months. But certainly, we are prepared even if they don't. Once we receive an approval, at some point in very short proximity after filing, completing that NDA, in Q4, the DEA then needs to reschedule because this is a Schedule I product.
Right now, the DEA is, by statute, supposed to reschedule a product of an approved medical use within 90 days. The executive order back in February asked the DEA to work in a timely fashion for psychedelics, so there could be a potential to shorten that timeframe from 90 days after approval. Then the states need to reschedule, which we've done a lot of work to prepare the states to reschedule within 30 days after DEA. All of this to say is we don't have a real good answer of when a potential launch will happen, but we feel very certain that it will happen in the first half of 2027.
How should we think about the label language that you're likely to receive for COMP360? I'm just thinking of how the product was studied in clinical trials. For example, would you expect the label to discuss things such as induction dosing, whether it's one or two doses, and how frequent can you redose in terms of maintenance?
Steve, do you want to take that one?
Yes, I'll take that one. We expect a fairly broad label to essentially say for the treatment of treatment-resistant depression. As far as the dosing, we have studied up to four doses in a year in our COMP006 trial. They were up to three in the COMP005 trial. We looked at an initial dose in two different ways. One was a single initial administration in COMP005. That was our placebo-controlled trial. In our three-dose, low-medium-high 006 study, we looked at two initial administrations, three weeks apart. What we have seen from that study with the two initial doses three weeks apart, as well as from the part B data, the blinded part B data from the first study, where that second dose was given a bit later, typically between weeks 10 and 14, is that for many participants, there was a significant additional benefit of having a second dose.
Ultimately, we think that that will translate into a label that may talk about initiation of treatment as two doses no sooner than three weeks apart, with additional treatment at clinician discretion or as clinically indicated. That will likely be a clinical decision, truly, because this is a heterogeneous population. One thing we showed in the part B section of both studies was a breakout of cohorts by initial level of response. You can see the trajectories of those patients, where some, just 24 hours after that first administration, are in remission, then may not need another administration for quite some time. Whereas others have received up to three or four doses over the course of 52 weeks. Ultimately we would expect, in the real world, patients to have treatment on a frequency of two to four times per year.
One thing that is important to point out with that is that currently the only pharmaceutical product that is approved in this population, treatment-resistant depression, which is a very different population than MDD, for which there are 50+ approved products, is that only approved product is SPRAVATO, which unfortunately does not have significant durability. It is administered typically on the order of 25- 50 times per year, which places tremendous burden on both patients and their caregivers that need to drive them to this treatment. Regardless of the final nuances of that label language, it will indicate that this is a treatment administered on a scale quite different from what is currently available to these patients today.
Do you have any expectations for how the REMS program might read? Given how we know what SPRAVATO's REMS program looks like, do you think there would be a similar patient monitoring requirement?
Yeah, I will keep going here. We, first of all, going back to some things already mentioned about the cadence that we have had the opportunity to engage with FDA, starting with our Breakthrough Therapy designation back in 2018, certainly more recently after they aligned to a rolling submission and review, now with our Priority Review Voucher. We have really had the opportunity to have a very engaged dialogue with the agency, and it has been very productive and constructive. As part of that, they have guided us in terms of their expectations for a REMS to look at the existing SPRAVATO REMS, as well as what they prepared in their briefing materials for the Lykos AdCom a few years ago, which is very consistent with the SPRAVATO REMS.
With that, we do expect a REMS that is very comparable to SPRAVATO, which fortunately has not been onerous to these sites. We believe that those who are delivering SPRAVATO today will deliver COMP360 when approved because it is exactly the same infrastructure, same rooms, same staff. So they are already used to working with the REMS that we expect to have for our product. The key difference just being the length of monitoring time required. For SPRAVATO, it is two hours. For us, we expect six.
Okay, great. I would like to pivot a little bit now to the commercial launch picture. Can you talk a little bit about what you have been doing with interventional psychiatry clinics to prepare them for the launch of COMP360? I believe there is about 8,000 or so clinics of this nature out there. Which of these clinics would you be targeting at launch, and how do these clinics think about integrating COMP360 alongside their current offerings, whether that be SPRAVATO or TMS or something like that?
Steve and I will probably tag-team this answer a little bit. You are correct. There are about 8,000 sites right now that are currently capable and certified to administer SPRAVATO. What that effectively means is that they are certifying that they can administer multi-hour treatments, with SPRAVATO being a multi-hour treatment. These sites are growing at about 500 sites a quarter. So whereas there are about 8,000 now, by the time we launch, if that trajectory continues, there will be quite a few additional clinics that will be prepared to administer multi-hour treatments by the time we launch. This has been pretty remarkable growth. These sites are growing because they are growing in anticipation of additional multi-hour treatments coming to market. Steve can certainly talk to how that is good for business for these sites.
Right now, given where we are at with the sites that do prescribe SPRAVATO, we are already thinking about what our sales force would look like. We have already started our sales force hiring to make their offers contingent upon approval, to which they will cover all of these 8,000 sites. Most importantly, they will also cover referring physicians. So those physicians that are surrounding outside of these interventional psychiatry treatment centers to make sure that physicians who have treatment-resistant depression patients in their practice understand what the opportunities are for new products coming to market. In terms of what we have already been doing with these sites, I will hand that over to Steve to talk about some of the work we have done there.
Thanks, Lori. First, we know these sites intimately, and the space intimately. I don't say intimately in a weird way.
Yes, you do.
I say it from first, a few words about my background prior to COMPASS. I've been here six years, but prior to that, between 2010 and 2020, I was leading a national network of mental healthcare delivery sites that operated coast to coast in 10 states that were the first examples of this type of infrastructure. Bringing that into COMPASS, not only understanding that business, but also many of the other sites that have opened in the period of time since then. We have done extensive work through a network of strategic collaborations, which is something that we put together. It's a bit unique. These are live sites of care currently taking care of people living with treatment-resistant depression that span the gamut of where they receive their care from community behavioral health to hospital systems, integrated models, decentralized models, and others.
Including the top examples in the country of interventional psychiatry, as in the highest volume prescribers of SPRAVATO today. Through information exchange over the past few years, it's really given us a very valuable opportunity at a very granular level to understand the challenges and opportunities of implementing new treatments within these sites. Also to realize, which is probably fairly obvious in the first place, that they did not build their sites to be SPRAVATO clinics. They built them to be platforms to deliver all of the approved available options that can serve this population. Because number one, they recognize that there are unmet needs, and they need new options for their patients. Number two, it's healthy for their business.
One of the reasons why we see that there is a lot of capacity in these sites now already is because they understand that COMP360 will be coming and other treatments behind us, and they've been building that capacity ahead to be ready. Additionally, one other thing maybe to mention is that apart from understanding them through our strategic collaborations work, we've also had a medical science liaison team out in the field for the past few years, meeting with all of these sites as well, having scientific exchange, answering their questions about our data.
Great. Well, thank you for that. I want to get even a little bit more granular here in terms of how the practice economics may play out, and I'm specifically thinking about billing and reimbursement and things like CPT codes. Do you expect that this will be a buy and bill product, and are the codes in place essentially to help ensure favorable practice economics?
Guess that's me. Yes. First, although it's not typical for a biotech or pharma company to be thinking about provider side economics, and ultimately it's not our role, it is important here because we are aiming towards broad and equitable access, and we know if this treatment isn't viable economically for these sites, they won't write these prescriptions. We did have a front row seat to some of the early launch challenges for SPRAVATO, largely, I mean, it's multifactorial, but largely because of the lack of a reimbursement framework in place for these providers to get adequate reimbursement for the multi-hour monitoring in office. Specifically, Johnson & Johnson did not apply for new codes, and therefore it started off in a very confusing situation where various codes were being used, and in many cases not reimbursed.
It's been somewhat ironed out over time, but ultimately they are not using codes that are specific to their product, and therefore reimbursement really isn't optimized. We were able to take a note from that. A few years ago, we applied for new CPT codes that are specific to the administration of psychedelic treatments in office. Those codes were approved. They are live in their Category III form and ready to be progressed to Category I with the approval of these new products. Additionally, you mentioned the buy and bill model. Buy and bill was brand new to psychiatry with SPRAVATO. It has taken some time to penetrate probably about 35%-40% buy and bill at this point for SPRAVATO. It is a big revenue opportunity for the sites, frankly.
We also believe the coding strategy that we are taking with our intention to apply for a J-code after approval will also optimize the buy and bill revenue for these sites.
Wanted to touch on the payer side of the equation. Could you just speak to any interactions with payers, the feedback you're getting there, and then maybe if SPRAVATO makes sense in terms of a pricing comp?
Yeah. We have already started our exchanges and dialogue with payers. We did that after the COMP005, 26-week data. We really could go to payers and start talking about what a product profile looks like and what the value proposition looks like. We've been doing that for the past several months. Feedback has been overwhelmingly positive. The reason it's been overwhelmingly positive is because they have only one product that they are covering right now in treatment-resistant depression. What that means is that there's only one product that has proven clinical efficacy in a patient population that does unfortunately cause tremendous disproportionate economic burden versus MDD to the healthcare system. When you can prove efficacy in a patient population like this, payers tend to react very favorably.
Payers in particular have been reacting to the fact that this product works in this patient population specifically. This product works within 24 hours for those who respond. If you take a look at some of the data that we've generated and that dramatic drop within 24 hours, this is a patient population that we studied that had been in their current depressive episode, their current episode, for three to four years. That is a very long time to be depressed. Then you take one dose of COMP360, and the very next day, you feel better. I'm way overgeneralizing, but that is effectively what is happening to these patients, and payers are responding well to that on top of physicians, on top of patients. All of that is great. The other thing that payers are starting to respond to is the durability of the products.
Not having to come back into the office to get treated again, only a handful of times over the course of a year is also highly interesting to these payers.
Bigger picture, how should we think about overall market opportunity here in TRD? For reference, I have some numbers here with SPRAVATO annualizing currently, I believe, north of $2 billion, something like $2.3 billion. Johnson & Johnson, I believe, has guided something like $3.5 billion in 2028. So how should we think about that overall market opportunity for COMP360? Maybe a follow-on there, do you expect that the majority of COMP360 patients would be sort of new interventional starts, or would there be any major switching over, let's say, from SPRAVATO?
Okay, David, we're on day 3 of conferences, so you're going to have to maybe remind me of some of these questions.
I got it.
My brain is fried. I will start with one question I didn't answer in the last one, which is pricing because that does help articulate what the opportunity could be. Right now, currently, on average, SPRAVATO is in the range of anywhere from $50,000 to $65,000 annually. We have, based on our discussions with payers, but also given the product profile and the value proposition that we're bringing, you can expect pricing on an annualized basis to be around that. We will be pricing on a per dose basis. Part of the reason why the 52-week data that we just released last week, which showed the benefit of having an additional dose after 26 weeks, really helped us to narrow in on what our average dosing on an annualized basis is likely going to look like.
We believe that will be somewhere in the two to four range, which means an average of three. The reason I say two to four is not to be silly, but it is to articulate that there will definitely be patients that probably only need two, and there will be patients that probably need four. The average will be somewhere in the three range. In terms of the opportunity, you are correct. Johnson & Johnson themselves are guiding to a $3.5 billion run rate for SPRAVATO by 2028. Guys, we're sitting at the end of 2026. There is no reason to believe that they can't hit that $3.5 billion. That would mean that they would slow down their trajectory as to what they've been doing over the past couple of years. We fully believe they will hit that.
They also will likely get some uplift based on all the things that Steve mentioned when additional products come to market. More awareness of treatment-resistant depression will help them. So we fully believe they're getting the $3.5 billion. In terms of what that means for us, they're only treating 2% of the available TRD patient population. They're treating 100,000 patients out of four million. There is not a shortage of potential patients who deserve adequate treatments that have been studied and proven clinical efficacy in treatment-resistant depression. So we feel very good about the potential patient population. It's probably important to note that we do not anticipate switches from SPRAVATO. Will we get them? Absolutely. As Steve mentioned, the burden to patients is quite profound for this treatment, but we're not going after SPRAVATO patients. These are treatment-resistant depression patients.
If they're stable and they're doing well on SPRAVATO, I don't want them changing to COMP360. Again, that is something that will happen, and we know that will happen, but it's not who we're going after. We have an entire market, an untapped market of treatment-resistant depression patients that will come in, and we also have many who can't commit to the SPRAVATO burden. That is 25 days- 50 days off of work on an annual basis that you and your caregiver have to take off to go and get treated with SPRAVATO versus the two to four that you may have to do for COMP360.
And just to expand on that one more step. The other benefit that we see with our profile, and only really having the patients come in two to four times a year, means that they are likely more willing to drive longer distances to get to a site. Now, with the expansion of sites, they are probably not going to have to drive that far.
But if you are on SPRAVATO and you are needing to commit 25 to 50 times a year, you want to be pretty close to that site. Because of the strong profile that we are seeing and how highly differentiated we are, we will likely be able to expand the radius around each site in order to bring new patients in. That is one of the reasons, in addition to everything Lori has said, as to why we are so confident in the potential for this product.
And then one more thing. On top of all that, but wait, there is more. This is specifically opportunity in TRD, but also worth mentioning that we have a late-stage program in PTSD, which is potentially even a larger opportunity. There are 13 million patients living with PTSD. There has been a lot of focus on our veterans, as there should be, but they ultimately represent a minority of people with PTSD, about 15%. The vast majority are women survivors of sexual violence. This is a terribly underserved population. There are only two approved products for PTSD, both of which are old generic SSRIs. They are modestly effective at best, and there has not been an approval in more than 25 years. We are in a late-stage trial now, a phase II-B/III, that is subject to review by FDA, designed to be a single trial for registration.
We are, especially based upon the data we have generated in a Phase II study we published last year, really excited about the potential there, and as I mentioned, really a very large opportunity to follow.
I appreciate, Steve, your very thorough responses to my multi-part analysis. Okay. Getting into the first year of the launch here in 2027, we know SPRAVATO was a little bit slow out the gate, but granted, the infrastructure back in 2019 had not been built. I think we have discussed that. How should we just think about the shape of the launch curve here in 2027 for COMP360 as this product makes its way to the market?
Yeah. We will be the first classic psychedelic to market, and that, yes, the infrastructure is there, and yes, they do understand how to get billing through. They understand how to get PAs. The staff is already established. There's nothing incremental that the sites will need to do to get prepared for COMP360. We're going to take extreme care to make sure that patients and the sites have a good experience. That includes having a field reimbursement team out in the field. We know the number one reason that physicians won't prescribe, and Steve alluded to it previously, if you don't get reimbursed or it's not easy to get reimbursed, they likely won't prescribe the product.
The patient has a bad experience because they're not well prepared, or they don't understand what is happening, or they themselves can't get the product reimbursed, then the sites will likely not prescribe. So we're trying to remove all those barriers, and because of that, it will take some hand-holding along the way to make sure that sites are well-trained, well-educated, and fully prepared, and can hopefully get the reimbursement codes through easily. Due to that, we anticipate the launch to be somewhat slow coming out of the gate, just because this is a new product, and sites are going to want to get a little bit of clinical experience before they start doing additional ramp. We do expect, if we do it well, that that ramp will be quite dramatic, and most likely be a pretty dramatic increase in fast fashion. Go slow to go fast.
Yeah, and we're seeing a tremendous amount of anticipation for this product, both from providers and from patients. So we're not seeing anything on the demand side for this not to take off. It's to Lori's point, we are purposely trying to help providers go a little bit slower at the beginning just to make sure everything is ironed out so that we can get to that full access that we anticipate, one, wants this product, and two, has access to it.
Great. So I thought maybe we could pivot a little bit now to discuss the competitive landscape and how this might play out over the next few years. So there is a competitor with an LSD-based therapy that is looking to come to market for both GAD and MDD. How do you think the profile of COMP360 and psilocybin here would stack up against an LSD-based product? For instance, are there qualitative aspects of the overall experience with psilocybin that may appeal to patients?
Yeah. First, I want to clarify that we do not view them as competitors. They are in MDD, we are in TRD. Two different patient populations. Their study was in a completely different patient population than what we studied in. Again, they are entering into a market with many MDD products available. We are entering into a market where there is only one product available. However, that being said, we want them to get to market. The more products that actually get to market, the better the economics are for these sites, the more awareness is around psychedelics and the potential for psychedelics for patients, the more patients that come into these clinics. I am going to hand it over to my psychiatrist friend down here to talk about what his feelings are about the difference between the two molecules.
Yeah. Well, first, just to pick up exactly where Lori left off, I think, and just to give a little bit more detail on the difference in the populations that we studied. In the recent psilocybin LSD data set, the average duration of an episode was about nine months. Whereas in our trials in a TRD population, that average duration, the chronicity of the current episode, was three to four years. It is well established that the longer someone has gone without successful treatment, the more difficult they are to treat. It stands to reason that you can move upstream, and if you have proved efficacy in the most difficult population, then your product will work well in a less chronic population. The opposite has not been borne out over time.
There are many products that are labeled and indicated for MDD that have tried to prove efficacy in TRD and not been able to do so. Just to further drive home the point that these really are different populations. To come back to some of the other points around the difference in the nature of the experience or at the patient level or what the implications might be for these sites. Number one, LSD is known to be a longer experience compound, and the challenge may be the delivery of their product within the typical operating day of a clinic. Beyond that, truly, as Lori is saying, this is not a competitive landscape in the sense of sites will be making these trade-off decisions.
First of all, at the time that we launch, the only real competitor, so to speak, will be SPRAVATO because it will be the only approved product in TRD. As I mentioned before, these sites have capacity. Any treatments they are delivering will be incremental. They will not be making trade-off decisions here. Beyond that, not any given patient will necessarily respond to any one treatment, and it is why it is important that there will be multiple options at these centers. Ultimately, no matter what treatment someone receives there, they may be receiving multiple of these treatments over time. That is good for patients to have those options. It is good for the sites for their practice economics. It is healthy for their businesses, and to the point already made, it is healthy for the sector because ultimately, this is good for the field of psychedelics.
It will grow the pie over time, increase awareness, and it just creates a very healthy system all around.
Lori, double-clicking into a little bit more why we are so well-positioned, being in TRD from a payer perspective. I think it does get missed a lot in terms of seeing the number of patients in MDD. There's an automatic assumption that means more revenue. That's not necessarily the case. I think it's important not only from a revenue side of things, but also just from a patient throughput. The point that Steve made around us having established data in this patient population is really important. I do think it's worth maybe just expanding on that a little bit, Lori.
Yeah, happy to. Earlier you asked a question about how things are going with payers. Again, the value of this data set in payers is they only have one other product that has proven through clinical trials efficacy in this patient population. Typically, what payers will do when they have limited options in, again, a patient subset that is disproportionately impacting the healthcare system, they respond very favorably to that data set. Typically, it is a different economic situation, in terms of negotiating with payers, in terms of formulary access than it would be versus a product that has MDD efficacy, along with five other branded products that they're covering on top of 50 different generics, but they're also trying to figure out how to make company step-throughs.
MDD products, although very valuable, we need more options, typically have different dynamics with payers in terms of negotiating to get to formulary access.
The other angle that has been looked at is the idea of a shorter acting psychedelic experience with some products looking to replicate an in-office profile that is more similar to SPRAVATO. How would you think about the landscape evolving if shorter acting psychedelic products come to market? In your view, is the duration of the experience a differentiating factor?
The short answer is no. The expansion on that is, first of all, even before we think about the differentiated economics of short versus long, or the fact that there is not a differentiation in those economics in an appreciable sense. It also ignores the idea of these molecules will not only be indication specific, but they will have differentiated experiences, both for the patients receiving them, the providers delivering them, there may be some considerations with some of those shorter acting products and what it is actually like to implement those. Just the very notion that a shorter acting compound that slots into the delivery window of SPRAVATO being more favorable does not hold up when you dig into the economics of that.
First of all, if you have a shorter treatment delivery, you still need to fill that room for the day because you are going to be paid for the time that you are seeing those patients, you need to keep that room full. That means you need to turn that room over multiple times during the day, which adds operational complexity. It also means that no matter how efficient you are, there will be downtime between patients when you are turning that room over that you are not paid for. Additionally, as it exists with SPRAVATO right now, because they do not have dedicated codes, the reimbursement is adequate. Clearly, it is on a $2 billion run rate.
It really is not optimized, what it means in terms of pure dollars for them is about $250- $300 per visit, they are blocking that room out for at least three hours, so it is less than $100 per hour. With the new codes, under any scenario that you model, because it is a formula that gets to the valuation of the codes, the fact that they are reportable on an hour-by-hour basis, that hourly reimbursement should be more favorable, actually.
It is a very good thing for the site to know that they can have somebody in the room for a longer period of time. It is going to be reimbursed that full time. By the way, while they are in that room, that patient is going to look like this. Everyone see this? It is a calm, pleasant look on my face right now. These sessions are largely silent.
This is generally a very uneventful monitoring period. There's very little the sites have to do. That makes this very easy for them, particularly when the broader proposition is generally safe and well-tolerated. You will likely know almost immediately whether this is benefiting your patient. If it does, then it will have a durable effect, such that they may only need a total of two to four treatments in a year.
Okay. Well, thanks for walking us through that. All right. I want to ask just about the, let's say, SSRI usage in this patient population. With TRD patients, I would expect that they have probably been exposed at some point, if not multiple points, with very limited effect. How do you think that SSRIs might be used once COMP360 is on the market? Do you see this as, is there a potential to use them as adjunctive therapy? Is it even possible that they may be added on and used to extend responses and remissions in patients treated with COMP360?
Yeah. It's been written a lot about lately that many people have difficulty withdrawing from serotonergic antidepressants. Within our trials, both of our phase III studies were monotherapy studies, and patients on SSRIs were withdrawn from them over a period of about four weeks. It actually went pretty smoothly. Most patients were able to tolerate a withdrawal within that period of time. That said, choice is always good, and there will be many reasons why patients or their prescribers may want them to continue on their antidepressants. Fortunately, we will have generated data through our trials that supports the safety of that co-administration and the fact that those who are on antidepressants have not had a diminution of the efficacy. I say that because in phase II, we had a 19-participant open label study where patients could continue on their antidepressants.
In our two phase III studies that run a full 52 weeks, within Part B, where it's still blinded, participants are given an option of a retreatment or to go back on an antidepressant. If they opted for the antidepressant in Part B, they were still eligible for open label treatment in Part C. This is how we have been generating data with co-administration as well. We fully expect a label that is agnostic. It won't say monotherapy or adjunctive. It will just say for the treatment of TRD, and there will be choice on the part of patients and their caregivers.
Okay, great. I know we touched on it in passing before, but I would be remiss not to mention the PTSD opportunity here. Perhaps you could just recap for us the data that you have generated to date for COMP360 in PTSD, and then just talk about what are the next steps there in development.
Yeah. The data that exists is the phase II study that I will describe more, as well as some academic studies, all of which have been really positive in terms of generating a signal of efficacy for psilocybin or COMP360 psilocybin in this population. Our phase II study was open label, 22 participants. It was largely designed as a safety and feasibility study. Because there had not been much data generated in this population prior, it was not yet known how people with PTSD would tolerate psilocybin specifically, and how to best monitor and support them within this clinical trial context.
To that end, this study was extremely reassuring in the sense that we supported patients with PTSD in the same way that we supported patients and monitored them in our TRD trials, which is very different than what had been looked at by Lykos in their MDMA psychotherapy assisted program, where these were very active sessions. They were really actively discussing their trauma. Very onerous sessions, both for the patient as well as the people in the room with them. In the case of our study, and going back to what I was saying about the typical experience in our TRD trials of somebody having COMP360, this was very well tolerated. In fact, in about half of cases, participants were not even thinking about their trauma during these sessions. Very well tolerated. It showed that this model was very feasible.
But on top of that, we did have an efficacy outcome measure, the CAPS-5, which was a very exciting signal with 80%+ of patients responding. With that, we have been moving full steam ahead with this late phase trial, and we really think this will be a highly differentiated new option for patients.
And for clarity, it is probably worth noting there is no psychotherapy as part of our trials in PTSD or in TRD, which has been misunderstood in the past. But to Steve's point, very inward journey, no interaction, no psychotherapy. Lori, you might want to touch on just the synergistic potential for this.
Yeah. Thank you. I would like to add two points, actually. I think Steve said this, but if not, I just want to reemphasize. This is a late-stage trial, and we have designed it as a single registrational trial. So, that is important to note in terms of timing of potential PTSD coming to market. In terms of synergies, this is highly synergistic with the exact infrastructure that is currently existing for treatment-resistant depression. So along with all the data that we will be generating in terms of safety and understanding of comorbidities with treatment-resistant depression, which we will be able to use with the PTSD filing, it is because of the synergies these patients are treated in the centers that COMP360 will be treated in for TRD.
Now we are coming up on time, so I will see if there is any questions from the audience. Otherwise, I can ask one to close us out.
Don't be shy.
Not expecting switches from SPRAVATO.
Okay. You are not expecting switches from SPRAVATO, but 25- 50 times a year versus potentially two or three. Is that not very likely to happen?
I think there is a nuance, and I will let Steve also answer. There is a difference between expecting versus targeting. We are not targeting SPRAVATO patients, but we do absolutely know that many of them will want to switch. Maybe you want to think about it from a clinician standpoint.
Well, I was going to say exactly the same thing, unsurprisingly. We share brains up here. On top of that, you are right. This is something we are hearing from many clinicians now that either their patients are having difficulty continuing on SPRAVATO because of the frequency of treatment. In fact, most do give up after six or seven months. Or they have had some benefit from SPRAVATO but really are not where they want to be. They are thinking that there will be many switches, but as Lori Englebert said, we will not be targeting.
Maybe just to follow up on the pricing dynamics.
Yeah
I'm sure I had this right. Some might only need two per year. It's a per dosing, so are you actually getting penalized for being more effective? Is that right, or is that not the problem?
It's part, obviously, the complexity behind how we end up pricing and to make the complexity even worse, SPRAVATO has two different doses in which they're priced at and a dosing paradigm for their treatment that makes the annualized number quite broad. We're taking all that into account when we think through pricing. That's really why we narrow in on three, so our average number, and so we will price on that annualized divided by three.
Thanks.
Yeah, sure.
Maybe I'll just fire off my final question since we have a second. Do you see opportunities for COMP360? We talked about TRD, we've talked about PTSD, but do you see broader opportunities in the neuropsychiatric landscape?
Yeah, definitely. Do you want to talk AUD maybe next?
Yeah. It does seem that classic psychedelics like COMP360 may have somewhat trans-diagnostic potential and may work across many indications, which gives a lot of choice. We certainly do see a lot of potential and a lot of need in substance use disorders and particularly in alcohol use disorder. We've also generated some data in some other indications through IISs that look very promising as well. We will be taking all of that into account and thinking about both the life cycle of COMP360 as well as potential future assets.
Just to add to that, I know we're up on time, but I think it's important. Right now we've got COMP360. We have early stage development work. We have a very large library of compounds that we just haven't been focusing on because we are trying to get COMP360 over the finish line. We have a library of over 1,000 compounds, many of which have pre-clinical data. We are also looking more extensively from a BD perspective to add to the pipeline, given we now have commercial infrastructure built and a late-stage development engine. We are a natural filter and natural consolidator going forward to build on our pipeline.
Okay, great. With that, we're at time. COMPASS team, thanks so much.
Thanks.
Thank you for having us.