Kabir Nath: So Charles, you’re not going to trick me into designing a Phase III study on this call. Suffice to say, obviously, we are encouraged by this data. As I said, we clearly are working on plans, development plans. We will need to take a robust outline of that to the agency together with this data to have that discussion. What that number of trials is, the sizing and so on, is still very much to be determined, but you have my assurance we will be doing it appropriately, trading off robust evidence and capital efficiency. Both of those will be goals in whatever design we put forward.
Charles Duncan: Confident in it. Moving on to TRD. Another question, you’re probably not going to be interested in answering, but I’ll ask it anyway. Can you provide any color on the number of patients or at least the kind of pacing of patients into Part B and even Part C in terms of retreatment on a blinded basis in Part B and then open label?
Kabir Nath: So you were right. The answer is no. I’m not going to give specific, except to say, as we’ve said, we clearly have patients in both parts. But also importantly, as we’ve also said that the dropouts are running significantly lower than what we have potentially anticipated in the trial, which I think is again a good sign.
Operator: And our next question comes from the line of Patrick Trucchio from H.C. Wainwright & Co.
Patrick Trucchio: Congrats on this very positive outcome in PTSD. I’m wondering if you can talk a little bit about the trial design for the Phase II study in PTSD relative to the FDA guidance for psychedelic drug development and discuss any of the learnings that have emerged that could have an impact or inform the potential Phase III trial in PTSD. And then secondly, I’m wondering regarding the pivotal Phase I trial in TRD with top line data expected in the fourth quarter. Can you frame for us what data you would expect to include in that top line release? And how we should think about the outcome from the study relative to both the Phase IIb trial in TRD as well as possible read-through to the outcome from the pivotal trial two in TRD where the top line data is expected mid-2025.
Kabir Nath: So I’ll hand to Guy in a moment. But I guess, just the first thing to say, a reminder, this Phase II was an open-label 22 patient study. But let me hand to Guy to say anything around the FDA guidance that will inform how we think about further design.
Guy Goodwin: I mean the FDA obviously expressed an interest in seeing comparisons with another treatment, and that can be placebo or it can be another dose of the active treatment or even an active placebo. So they’ve left really quite a wide range of options for anyone developing a drug in this space, and we’ll take that into account when we think carefully about how we design our Phase II and indeed Phase III program for PTSD. I don’t think there are tremendous differences between TRD and PTSD from what we’ve seen. But of course, the advantage of a shared safety database with TRD, there’s not to read across the PTSD indication.
Kabir Nath: And on your second question, Patrick, again, we have not guided to what exactly we’ll be in a position to release with top-line. As you’re aware, Part B runs to 26 weeks blinded, so we’re going to have to be sensitive around that in terms of that. And look, we have powered and designed this study for success, clearly, and we believe that any significant result will be very positive and further evidence of the potential for COMP360 and TRD. And I don’t know, Guy, in terms of any read-through from 005 and 006, if you have any comment you want to make?
Guy Goodwin: Not really. I mean, I think we see 006, I think as we’ve said before, Patrick, we see 006 as being particularly informative from a clinical perspective rather than simply a regulatory one. And that it will help us to understand the number of treatments that are probably required in ordinary practice potentially going forward, which is essential to the commercial model and to the acceptability to clinicians and patients as well.
Patrick Trucchio: And if I could, just on this — on the commercial collaborations following another announced today. I’m wondering, do you have an estimate or an expectation for the proportion of the TRD population you may be able to reach at the time of the potential launch based on these commercial collaborations or how significant should we think about these collaborations in preparation for possible rollout of COMP360 in TRD?
Kabir Nath: So to be clear, these collaborations are already learning exercises. They are examples of different settings of care. And while some like for instance Greenbrook TMS, we would expect potentially to be numerically a significant contributor to commercial rollout. Other, this is all more about building template, understanding delivery models that we will then need to apply to a wide range of other health care settings. So what I would say at this stage is you could think of them really as this learning experience, really to deepen our understanding of the potential, to deepen our understanding of these different areas. But assuming we’re fortunate enough to file, you could imagine that the year pre-launch is when we will be really scaling those templates across a number of those different settings and different healthcare providers.
Operator: And our next question comes from the line of Tom Shrader from BTIG.
Tom Shrader: It’s a remedial one on PTSD. So patients with your baseline score, what level of impairment do they have, what level of medical care are they using? And would a group like this at some level support the same price as your TRD patients?
Guy Goodwin: They’d be classified as severe. And one of the criteria for the way in which one scores the CAPS-five is that it would merit intervention or require intervention when people score two or three, particularly on the scales that are used for each item of symptom. It’s a complicated scale, I’m afraid. So it needs a little — we will be unpacking it a little more in the future. But that gives you some idea that these are a group who would need treatment, but they’re not a group who are sort of mild and coming in for the experience.
Kabir Nath: Yes…
Tom Shrader: Any background on how much they’re hospitalized?
Guy Goodwin: We don’t have all of the data on these patients yet. This is very much top line. So when we get all the tables in, we’ll be able to give you that color.
Kabir Nath: And roughly half were on something an SSRI or antidepressant or something.
Guy Goodwin: Yes, I think all have received previous treatment of some kind. Sorry, if that was the question, then that’s the answer. That included psychotherapy as well as drug treatment. And about half were actively still on drugs, which we then discontinue.
