Jason Gerberry: Hey, guys. Good morning and thank you for taking my question. On ITI-1284, I’m not seeing this on CT.GOV yet, but maybe I’m missing something. But just generally trying to get a sense, how big are these trials? How many dose arms? Are these going to be like 12 week treatment period to get proof-of-concept and figure out dose? And just trying to get a rough sense of time line here ultimately. And then just as my follow-up, if I can squeeze it in. I didn’t hear an update on mixed features. I think you guys were waiting for the minutes, which tend to come like I think 30 days after the meeting. So just curious if there’s a mixed features update. Thanks.
Sharon Mates: I’ll start with the second part, and then I’ll ask, Suresh to chime in on the first part. So we did update you on the mixed features and said that we would come back to you after, our readout of 502, and as we continue to put together our strategy for mixed features in MDD. So stay tuned. Hopefully, in the near future, we’ll have some updates for you, on the mixed features. And I’ll give you the short answer on 1284 as we will be posting, these studies, we said, before the end of this quarter. And I’ll leave it to Suresh to talk to you about the design and powering of these studies.
Suresh Durgam: Yes. Regarding the 1284 studies, we have three programs right now. That is the GAD program, the psychosis in Alzheimer’s disease, and agitation in Alzheimer’s disease. The first study we will be starting is the GAD program. That is a fully powered study, as a registrational study. It’s as an adjunctive treatment, and it is, sample size would be somewhere in the range of about 600 patients. It’s going to be three arms, placebo versus two doses. Again, the details once we start the trial, soon in the next few, we will be posting that online for the ClinicalTrials.gov. Similarly for the agitation and psychosis in Alzheimer’s, those are Phase II studies, but are powered as registrational studies. Those details also will be posted as soon as we start the studies. And they are intended to start this in the second quarter.
Jason Gerberry: Got it. Thank you.
Operator: Please standby for the next question. The next question comes from Sumant Kulkarni with Canaccord. Your line is open.
Sumant Kulkarni: Hi. Thanks for taking my question. Sorry about the two parter. So on the last MDD data focused call, I know you’d requested me to hold off on this question until this update, so I’ll ask it now. 1284, are you planning to specifically develop that product in the various sub indications of depression? And on Lumateperone for autism spectrum disorder, I’m asking because unmet need is high. How is the company thinking about dosing for pediatric patients? Is there a weight based dosing paradigm or will it be as simple as the product that’s out there in the market right now in terms of logistics around dosing? Thanks.
Sharon Mates: Suresh, you want to take the second part and then I’ll need you to repeat the first part.
Suresh Durgam: Yes. Regarding the second part about the autism in for Lumateperone, we are going to be starting those studies for irritability in autism. And regarding the dosing, we are looking at we have to finish first finish the PK studies, for the lower age group, between 5 to 10 years old. Based on the PK exposure levels that comes from that study, we will be deciding on the dosing for those patients. For patients in the upper age group, it will be similar to what, it is in in adults. For example, from 13 to 17, it will be — it will be similar to 42 milligrams. So the lower age groups, we have to figure out by the PK studies.
Sumant Kulkarni: Got it. And the first part was on 1284, we know you’re developing it for Alzheimer’s disease psychosis and agitation and generalized anxiety disorder, but are there any specific plans to develop that within the depression context?
Sharon Mates: Yes. Well, we are contemplating other indications within 1284, but let us get these studies started first and then we’ll come back to you with the other studies that we’ll be doing.
Sumant Kulkarni: Thank you.
Operator: One moment for the next question. The next question comes from Jeffrey Hung with Morgan Stanley. Your line is open.
Michael Riad: Hi. This is Michael Riad on for Jeff Hung. Thank you for taking our question. Thinking more generally about the results from Study 501 versus 403. How important is it to get DSM-5 classifiers into the label versus a more broad label like adjunct MDD? I guess I’m just trying to ask what happens more regularly in standard clinical practice and to what extent do classifiers influence treatment decision? Thanks so much.
Sharon Mates: So I think our broad label, is obviously what we always aim for and what we’re doing is exploring value of having anything, you know, specific in any label that we have. And, again, as we — as we get the 502 readout, we’ll come back to you with further updates on exactly what it is that our strategy is now and will be. Mark, did you want to add anything to that?
Mark Neumann: No, I think that’s good.
Sharon Mates: Okay.
Operator: One moment for the next question. The next question comes from Graig Suvannavejh with Mizuho. Your line is open.
Charles Wang: Good morning, everyone. This is Charles Wang on for Graig. Thanks for taking our question. Given Study 501 indicated a very strong placebo adjusted effect size of 4.9. Does the company expect to see similar efficacy in Study 502?
Sharon Mates: Yeah. That was a point change. That wasn’t the effect size, but the effect size was very strong as well. And I think what you’re looking for, the studies are powered to show actually, this study was powered to show a two point change, because in adjunctive studies, typically, you are at the lower end of the two to four point change in the MADRS that you’re seeing. So I think we’re very close to the data. We hope very much that we have as strong a readout as we saw in 501, but no two studies are alike. And you can, as you know, if you look at precedent at other studies there you know no two studies are exactly the same even within a program. So we look forward to seeing the data and we’ll update you as soon as we get it. Suresh, did you want to?
Charles Wang: Okay. Thank you.
Sharon Mates: Sorry. You okay?
Suresh Durgam: No. That’s correct. Yeah, I would agree with that.
Sharon Mates: Okay.
Operator: One moment for the next question. The next question comes from Troy Langford with TD Cowen. Your line is open.
