And this gives us actually probably an interesting position from a timing perspective, to prepare now a dialogue with the agency to share our data with the small molecule, which has the advantage of being easily administrable, does not have any challenging procedures. You don’t need a PET study upfront, you don’t need an MRI study upfront or during the treatment, and you can just go to the physician and be assessed and have Alzheimer disease, and the physician will say, take this capsules or pills and come back in a few weeks or months again. And so this is really a big advantage from our procedure. There’s also no requirement to have a demonstrated level of a better in the brain because in our study it was not required. We measured a better in the brain, but it was not an entry criteria.
So the entire population of the Alzheimer population in the world, including every region would be basically the entire population would be something ANAVEX2-73 blarcamesine could be considered as a target population, while the antibodies only can target patients with MCI in a certain level or threshold of a better in the brain. And it turns out not all patients with Alzheimer have that threshold, that high threshold of a better in the brain. So they would not be eligible for an antibody treatment. So that basically means that the available population in Alzheimer disease is much larger for blarcamesine to penetrate than for the antibodies. So this is a long winding answer. So we are proceeding with this dialogue.
Tom Bishop: So would – do you plan perhaps to speak to the FDA soon or are you scheduled to, or have you already to make your case?
Christopher Missling: We’re planning to [indiscernible] what I just said and the timing could not be better.
Tom Bishop: Okay. Great. And as far as Rett goes, what I sort of heard you say was given that the data for a A2-73 was even better than the drug that recently got approved, except for how the placebo went. Is it possible that the FDA might just go ahead and encourage you to file for approval based on this data?
Christopher Missling: We don’t know and everything is possible. That’s why we said we want to reserve and analyze the data completely and then discuss this with the agency. And then we take the next steps from there. So – but we cannot promise anything. But again, as I mentioned before, there’s a very easy way to address this as a backup plan, to have just another study, a 12-week study, and putting in place all the features which would not allow for a placebo response as we have seen, larger study, similar size to trofinetide, and also other features which can be included.
Tom Bishop: How big was the study again?
Christopher Missling: Pardon me. 12-week.
Tom Bishop: How big was it though 180…
Christopher Missling: 180 patients, I think run about 180 patients total. So randomization 90/90, active arm placebo equally randomization [ph].
Tom Bishop: Okay.
Christopher Missling: Now – Phase 2 was – Phase 2/3 study was half of this size, with a caveat that we had only 30 patients in the placebo arm. And these measures are very noisy, as we have noticed. And so unless you get unblended maybe, they are noisy and they’re just not measures which are perfect and that’s what we noticed. But there are ways to address it to avoid this noisiness. And now we can implement that.
Tom Bishop: Okay. Well, Godspeed. Thank you.
Christopher Missling: Thank you.
Operator: So I don’t see any other questions at this time. Dr. Missling?
Christopher Missling: Thank you. Again, this is exciting progress in the field relating to treating neurodegenerative diseases highlights the significant potential for our broad therapeutic portfolio and differentiated precision medicine platform to deliver easy access and scalable treatment options demonstrated by the initiated process of Marketing Authorisation Application to the European Medicine Agency, EMA for blarcamesine related to the treatment of Alzheimer’s disease. We continue to focus on execution and commercial readiness, as we advance our therapeutic pipeline to potentially improve patients’ lives living with neurodegenerative, neurodevelopmental disorders and schizophrenia. Thank you.
Operator: Thank you all for participating today. This concludes our conference. You may now disconnect.
