It does impact the longevity of their disease. So one of the challenges is really identifying the right patient profile. So to that end, that’s one of the challenges that we’ve encountered, but we believe that the therapy has a great potential of being a novel therapy that will work in that population. But again, I think the landscape is trying to catch up and really clinically understand what that profile looks like. So that’s been a limiting step for that program. But we’re continuing to move it along. We’re continuing to identify the sites that have access to the right patients, because that’s really critical to get the signal detection that we need for success. So that’s where we are with that program now.
Ron Renaud: And, Ray, the other question was of darigabat, for the real-life study, what are you looking for success?
Ray Sanchez: Right, right. So for epilepsy, for darigabat, so remember it’s 80% powered to detect at least a 30% placebo adjusted difference in reduction of seizure frequency. So if we achieve that, that’s terrific. As you know, we’ve got the Xenon product, we’ve got cenobamate that have had very compelling outcomes which fall into the mid-30s. Keppra falls around 28%. So if we achieve our 30% threshold and above, that would be really a successful outcome for us. So we’ll stay tuned for that and based on that data, it’ll allow us to then tailor our Phase III program accordingly. But based on the mechanism of action selectivity of this GABAA PAM compound, we are very hopeful that this will introduce a novel therapy that will benefit patients with epilepsy.
Jeff Hung: Great. Thank you.
Ray Sanchez: Thank you, Jeff.
Operator: Thank you. One moment for our next question. And our next question comes from Graig Suvannavejh of Mizuho.
Unidentified Analyst: Hi. This is [EL Wang] (ph) for Graig Suvannavejh. Good morning and thank you for taking my question. Congrats to the team for the recent capital raise and just two quick questions from us. For emraclidine, what is needed from non-clinical and clinical pharmacology studies in order to support a potential registrational package in schizophrenia and to what drove the decision to proactively raise equity capital ahead of your multiple clinical data events in 2024? Thank you.
Ron Renaud: Sure. Thanks for the question. Yeah, so we have been looking forward to getting the package ready to submit to the NDA. So to summarize briefly, we’ve done almost all the work that we need to do actually to prepare the preclinical section of the NDA already. So we have a few things to finish up, but there is nothing that’s going to be on the pre-clinical path from that area at all. So I hope that addresses your question. Yeah, and then — I think on the capital raise, I’ll let Susan add to this as well, but I think largely this was one thing that we had been talking to a number of investors about over the last few months and there was a significant amount of interest in doing the raise from outside investors. And so we thought it was a good time to do that so that we could really be focused on execution in 2024.
As we mentioned, we’re going to be working on two NDAs in parallel. And so to be able to have the balance sheet shored up and really have a line of sight and focus on execution on those lead programs was really the primary driver behind that. I’m not sure if there’s anything to add to that, Susan.
Susan Altschuller: We’ll continue to be judicious with our spending. I mean ultimately, what the capital raise enabled us to do, as Ron said, was focus on execution. The runway gets us into 2026, so we can turn over the data cards next year and not have any overhangs limiting our upside potential.
Unidentified Analyst: Perfect, thank you.
Operator: Thank you. One moment for our next question. And our next question comes from Charles Duncan of Cantor Fitzgerald.
Charles Duncan: Yes. Good morning, Ron and team. Thanks for taking the question. Congrats on the progress. Had a quick question on emraclidine and one follow-up on darigabat. Emraclidine, the ADP study, I’m wondering if you could give us a little more color on timing of data and really the kind of rate limiting step for enrollment of that study and what would — what’s the key parameter that you’re looking for or looking at to decide whether or not to move forward in ADP?
Ron Renaud: Yeah, Charles, so as we’ve talked about in the past, this is more or less a first-of-its-kind type of study and right now we’re in healthy elderly volunteers. And so we haven’t — to that end, we haven’t given any guidance on when we expect to enroll that study in terms of — I’ll let Ray address how we’re thinking about the indication itself, but just stay tuned on that. That’s something that we will continue to move ahead and we’re looking forward to, but we’re not going to provide any guidance on enrollment on that program at this time.
Ray Sanchez: And to follow up with that, Charles, for ADP, currently we’re doing, as Ron mentioned, multiple ascending dose trial in healthy volunteers. There’s other work that needs to be done subsequent to that that will allow us to understand the dosing in that population which is important because it’s very different manifestation symptomatically but also population in terms of the psychotic symptoms that they experience, mostly hallucinations and delusions. The good news is we got fast track from the FDA, which will allow us to work closely with them in terms of what does that development program look like, so stay tuned for that.
Charles Duncan: Okay.
Ron Renaud: And then, Charles, I think you had a follow up on darigabat?
Charles Duncan: Yep, yep, quickly. Just, I think Ray mentioned that he’s encouraged with high rollover rate. Probably not a surprise in focal onset epilepsy if there is perceived efficacy. So I’m just wondering what a high rollover rate means and more importantly, what do you see in terms of persistence in that open label part of that study? Thanks.
Ray Sanchez: Yeah. So, Charles, obviously we’re always encouraged by patients rolling over into the open label extension, meaning that they are tolerating the therapy well in terms of efficacy. It’s really hard to really understand that because the data is blinded and it’s in the patient’s purview to roll over. They feel that there’s benefit or they want to continue with the therapy. We can comment on the open label extension data. That will be disclosed when we lock that database and that data becomes available mid-year next year. So while we review the data for data quality, we don’t review it in terms of patterns of anything other than that at this juncture. So, we’ll stay tuned for that data readout in mid-2024.
