Sergio Traversa: So we will have, not we but the data monitoring committee will have a look at the data at some point close or be very close to the end, but this is not an interim analysis because there is no statistical penalty. It’s a simple re-estimation. They will let us know if the sample that we have in the trial is enough to reach statistical significance or if we have to expand the trial. So there is no early stop planned.
Andrew Cutler: The other major function of the DSMB, of course, is to monitor safety. And the good news is the safety and the tolerability has looked very good.
Andrea Tan: Great, thanks so much.
Sergio Traversa: Thanks, Andrea.
Operator: Your next question comes from Andrew Tsai from Jefferies. Andrew, please go ahead.
Andrew Tsai: Yes, congrats on the progress. This is Matt calling in for Andrew. And I guess continuing with the same theme, do you have any specifics on a number of the sites that you’ve had to pause, close or been able to even reopen? Are you seeing your monitoring real-time analysis? And then…
Sergio Traversa: Sorry, I can, no maybe it is me, but I can barely hear you.
Andrew Tsai: Okay, can you hear me better now?
Sergio Traversa: Much better, yes thank you. Sorry for that.
Andrew Tsai: Okay, no problem. So yes, I was just asking continuing with the real-time analysis, if you’d had any specifics on the number of sites that you’ve had to pause, close or maybe even reopen? And then also over the past year, we’ve seen quite a few companies that have announced delays, for instance, like schizophrenia and epilepsy spaces and are you seeing an increased level of competition in terms of finding the right entity, depression patients?
Sergio Traversa: Thanks for the question. Yes, thank you, very much for the question. So in terms of sites, like the site selection is not like it’s fixed like you decide 50, 60 sites at the beginning and you finish with the same sites. It is an ongoing process. So constantly there is a revision of sites and some site is closed, not only for quality issue also for like in the competing studies or for the date, they are exhausted the patient population that they can enroll into the site. So it is an ongoing. I don’t have on the top of my mind like a really specific number, but it’s not like that. At some point you do a review. It’s an ongoing process. So maybe, Andy, when I finish the other answer, I can give you a little bit more details because we run a clinical site. So it is more and more into the detail of the process. And the second question, would you mind to repeat it?
Andrew Tsai: Yes, just…
Sergio Traversa: Competitive dynamics?
Andrew Tsai: Yes, exactly.
Sergio Traversa: Yes. Well, there is clearly there is some competition out there and mostly I mean, usually a site does not, cannot or does not take on like three, four studies that enroll the same kind of patients. In our case, it’s a little bit particular because we are doing — the studies are for adjunctive treatment of depression study that the competition is much less. Then on many other programs, especially in Phase 3 that that enrolled patients in is adjunctive. We do believe there was one other company that finished the one sizable big study, a few weeks ago. But I do believe that the majority of the assays that were outside the U.S., so there was relative competition. It was not an antidepressant anyway. We keep on hearing that the psychedelic, the psilocybin, there are lot of trials ongoing with psilocybin in depression, that is not really a direct competitor, but still it keeps the site busy.
And this high dose psilocybin for PTSD and MDD. So to summarize, yes, there is competition, but we are in it like in a specific indication where the competition is much, much lower. Andy would you mind to provide a little bit more color?
Andrew Cutler: Yes, I’ll answer the second first, and that is that Sergio is exactly right. At the site level, you don’t want to take too many competing studies. Usually though the study criteria are different enough that you can do say two or three depression studies without significantly impairing, does a patient will more clearly fit into one protocol than another. So as far as the first question, I don’t have the exact number of sites that we’ve closed down offhand, but sites do close for various reasons, that’s certainly true. But we have stopped enrollment at a couple of sites, so I can say that, but it’s not a lot fortunately, and I think some of it is simply the process of overseeing the sites. Now the sites know that they’re being watched. They know that we’re monitoring quality and that often changes the behavior enough so that significant corrective action isn’t necessary.
Andrew Tsai: That makes sense. And then I guess regarding the Phase 1 psilocybin program that you’re going to be kicking off soon, can you describe the study design and what positive data would entail?
Sergio Traversa: Yes, it’s very simple. We’ll start with a Phase 1 single dose, ascending dose of psilocybin modified release. So the interesting part is the patient population or the technically Phase 1, you do it in a healthy volunteer and but it’s well known that psilocybin is a relatively a safe product at high dose and we are using a dose very, very, much, much lower like 120th, 130th of the dose that is used as a psychedelic for the treatment of psychotic diseases. So on the safety side, we feel extremely comfortable. But the indication that we’ll pursue for psilocybin is into the metabolic space, so obesity and glucose and fatty liver. So the data that we are looking for is the mostly PK data in obese patients. So the particular is the patient population that will be obese healthy volunteer and which will start over the next month or two and we said the within the first half, we are getting there.
