Operator: Your next question comes from Andrew Tsai, Jeffries.
Dina Elmonshed: This is Dina on for Andrew. We just had a couple of quick questions. What are each of your two Phase 3 studies sort of powered to show in terms of MADRS separation versus placebo? And a question for Cedric. Operationally speaking, how can you say with high confidence the study integrity for the two Phase 3 studies in 1017 are similar to how Axsome successful studies were run? Are you seeing a lot of similarities between those two programs and if you could just elaborate on?
Sergio Traversa: Maybe Cedric should answer that. I just would like to try to answer your last question on the comparison with Axsome. Cedric runs both the trials, running our trial and run Axsome trial. But these are very, very, very different drugs. So I don’t know how much would be reliable to compare the two programs. And, Cedric, do you want to try to answer?
Cedric O’Gorman: I think that anybody who’s in the drug development space, particularly in major depressive disorder, very much tries to run as high quality a program as possible. And that really comes down to three things, the protocol, the site selection, and subject selection. And so, it doesn’t matter which sponsor you work for, you want to have a very tight, efficient protocol that aims to reduce placebo response. And then you want to work with the best sites that are conducting MDD trials. And of course, those of us who work in clinical research for depression know that there are always the same sites known to the sponsor. So, you would expect that there would be knowledge and familiarity because these sites are the best in major depressive disorder.
And then, you just have to very carefully have an eligibility process that makes sure that you’re getting the right patient with confirmed diagnosis of MDD and you’re avoiding professional patients. And you’re doing everything from a subject selection process as well that might minimize recruiting or enrolling patients – or subjects, I should say, who might be prone to having a high placebo response. So you do that across the program, and I have to say that I’m very pleased with how rigorous our eligibility process is in letting subjects into the trial. And the question on the statistical powering, we haven’t actually revealed that yet. So, it would be reasonable to – if you take the Phase 2 data and if you were to consider 301 or 303 where placebo was controlled to about 10 or 11 points improvement on the MADRS, you could probably figure out how we’re powering it because we are targeting approximately 300 subjects, as Sergio mentioned at the beginning.
So I hope that helps a little bit there with an answer to your question.
Sergio Traversa: Just one quick point. According to the KOLs and the history literature, a difference in MADRS score versus placebos, 2, 2.5 points is considered clinically meaningful and enough for approval. So, you may imagine that we will file the statistical plan according to these parameters. So, the statistic will be set up to detect a MADRS difference from placebo that is clinically meaningful and good enough for approval. Hope I answered appropriately your question.
Operator: [Operator Instructions]. Your next question comes from Yatin Suneja, Guggenheim.
Unidentified Participant: This is Salma [ph] for Yatin. So I have a few questions on the psilocybin program. I just wanted to ask you if you have already filed the IND for the Phase 1 trial and how many doses are you planning to use there. Are any of these doses expected to trigger a psychedelic experience.
Sergio Traversa: I answer – Sergio here – the first part of the request. And then if you don’t mind to repeat the second one because I couldn’t hear you very well. No, we haven’t filed the IND. We are on the process to prepare the IND and I do believe will be filed relatively soon. But we are planning to start the Phase 1 single dose ascending in Q1 next year. So let’s say, two, three months from now. Can you please repeat the second part?
Unidentified Participant: I was just asking how many doses you are planning to test there. And if any of these dose is expected to trigger a psychedelic experience?
