Charles Duncan: Thank you. Look forward to the progress.
Ray Sanchez: Thank you, Charles.
Operator: Thank you. One moment for our next question. And our next question comes from David Amsellem of Piper Sandler.
David Amsellem: Hey, thanks. So just a couple of quick ones. Looking more broadly at emraclidine, how important is it to develop it and explore clinical work as an adjunct to D2 blockers? How do you think about that commercially? And then secondly, as you look at the kappa, can you talk about what you think makes sense in MDD vis-a-vis monotherapy or adjunctive therapy and how you’re thinking about it based on the body of data for the year competitors and what you’ve seen to date? Thank you.
Ray Sanchez: Okay. So, hi, David. So in terms of adjunctive treatment, we are very encouraged that we do believe that emraclidine will be a best-in-class muscarinic agent with once-a-day dosing, no need for titration and a very benign tolerability profile. No doubt that adjunctive treatment plays a role in the clinical landscape and probably has utility. The first step is for us to really understand the dose range in the trials that we’ll read out in the second half of next year. Following that, then we will pursue other programs in schizophrenia. Adjunctive treatment may potentially be one of them, so we’re not going to comment on that just yet because we really want to understand the profile of emraclidine and schizophrenia first before we consider it as an adjunctive treatment.
In terms of KORA, MDD monotherapy versus adjunctive therapy, as you know, there are two companies that have done — one has done a monotherapy, a second one has done adjunctive therapy. If you look at the outcomes of those trials that really are very similar, the monotherapy to what standard of care is shown and the adjunctive treatment is very similar to what the standard of care as adjunctive treatment, basically the neuroleptics have shown. So if you think about the value proposition of KORA in as adjunctive treatment to displace the neuroleptics because of a better tolerability profile based on the neuroleptic tolerability profile, that seems like a very exciting approach and also has great commercial and also potential, but also in the best interest of the patients.
So we think that that’s probably the best approach, but we’re evaluating all that. We’re continuing to understand our KORA compound internally, which we believe has the potential to be another best-in-class therapy. So we’ll stay tuned for all that moving forward.
David Amsellem: Okay. That’s helpful. Thank you.
Operator: Thank you. One moment for our next question. And our next question comes from Joseph Thome of TD Cowen.
Joseph Thome: Hi there. Good morning. Are you able to hear me?
Susan Altschuller: Continue.
Joseph Thome: Yep, perfect. Thank you. Great. Just a quick question on the tavapadon filing strategy. I think it was mentioned earlier that it was going to be a 2025 submission. So would early and late Parkinson’s be filed together and is there anything else aside from the open label that is kind of gating to that submission? And then maybe a second on the panic disorder study for darigabat. I know there’s a minimum number of panic attacks that patients need to have, but is there a maximum number that patients could have given that the primary endpoint is panic attack freedom? Thank you.
Ray Sanchez: Joseph, thank you for the question. So for tavapadon, yes, we plan to file in 2025. As you know, those studies will read out next year. Nothing is gating. In fact, the open label extension has progressed well and those exposures have been met. So we’re excited about that potential in the Parkinson’s arena. In terms of the panic program, you are correct that they have to have at least eight panic attacks in the month prior to screening and then four panic attacks in the two weeks of screening in order to qualify for the trial. So we don’t have a floor effect. We actually can show that there is potential to reduce panic attack symptoms, but there is no maximum. So it’s really around meeting the minimum threshold, and then from there you can have as many panic attacks as the patient is experiencing.
We’re really wanting to ensure though that we get the right patient profile that really drives success and that’s why that criteria is set that way and there’s precedent for that. So we are continuing to enroll in that program and excited about the potential of darigabat really being an innovative therapy and a needed therapy in the anxiety disorder space. So we’ll stay tuned for that data in the future.
Ron Renaud: Hey, Ray, part of Joe’s question about filing for tavapadon was, is it early and/or late? Could you just give a little more detail on how you think about the filing for tavapadon?
Ray Sanchez: Right. So when we file the tavapadon NDA, we will file all three trials and the open label extensions. So, we will get a label like others have received for the treatment of Parkinson’s disease. So, the NDA will consist of the TEMPO-3 trial, which we’ll read out in the first half of next year, which is the adjunctive to levodopa trial, the two monotherapy trials that we’ll read out in the second half of next year, as well as the TEMPO-3, which is actually the — excuse me, TEMPO-4, which is actually the open label extension trial.
Joseph Thome: Perfect. Thank you very much.
Ray Sanchez: Thank you, Joseph.
Operator: Thank you. I’m showing no further questions at this time. I would like to turn it back to Ron Renaud for closing remarks.
Ron Renaud: So, I’d like to thank everybody for joining us this morning. And keep in mind, again, I just remind folks about our tavapadon investor event on December 11th. Thanks, and we’ll talk soon.
Operator: This concludes today’s conference call. Thank you for participating and you may now disconnect.
