Daniel O’Connell : Well, yes, thanks for that question. There’s a lot to dive into there. Yes, as far as the CTAD presentation, there are a lot of biomarker effects that will be interested, things like phosphor tau and plasma or spinal fluid, I think, will be important for both actually compounds, lecanemab, and gantenerumab. I think one of the important things about lecanemab, based on our press release, is that at least according to the press release, they were seeing very early separation between drug and placebo and the clinical measures, even at six months, which is fairly remarkable. So we’re going to take a close look at the time course of the effect, which — and again, kind of seen the graphs in the press release, but you expect the effect to grow over time with the disease-modifying therapy.
So we’ll be looking carefully for that. So I think those are — there’s just a lot to look at in those studies, and they will guide us in terms of the design of our Phase 2/3. As far as your other question regarding the Cogstate computerized battery and its relationship with the CDR. Even in our Phase 1 study, we are measuring — we’re doing the CDR and obviously, we’re doing the Cogstate battery. This will be a small sample size, but it will be the first attempt to actually see how those measures line up with each other. The CDR, as you may know, there are six items, three of those are taken of measures, three or more functional measures. That’s a little bit different than our Cogstate battery, where these are all computerized tests that you have to say we were just cognitive measures.
So there may be a little dissecting out to be done, too. But again, the reason for putting the computerized testing in the Phase 1 study to start with is we think it should have less variability than the CDR sum of boxes, which does have a certain amount of subjectivity to it. And actually, especially in a small Phase 1 study would give us a better chance of picking up front signal if one is there.
Charlie Yang : Thank you. Just a quick follow-up. Regarding the potential timing for Phase 2 initiation, is 2024 still roughly that time frame for the trial to initiate? Or is there going to be — has some sort of delay to either late 2024 or early 2025?
Eric Siemers : Yes. So Charlie, we have just guided the notion that we are looking to start that Phase 2/3 study as expeditiously as possible. We recently did receive the Fast Track designation from the FDA, which we think is going to be kind of reaffirms our notion that 193 is potentially meets it as a large unmet need. We’ll use the Fast Track as well as, I think, our previously disclosed plans to have an FDA engagement, principally around an end of Phase 2 type interaction with them to discuss the merits of the Phase 2/3 design. We obviously will need the data set from INTERCEPT-AD as part of that briefing document, and there will be some regulatory time associated with the review in the discussion. But I think our goal is certainly to launch that Phase 2/3 study in early 2024.
And I don’t think we can guide beyond that, but I do think it’s a — based on our best estimates, certainly a 2024 event. And early in the year is our stated objective internally with the team.
Charlie Yang : Great. Thank you.
Alex Braun: Great. I think that’s it for Q&A
Operator: I’m showing no further question.
Alex Braun: Okay. That’s it for Q&A. Thank you so much for your interest. And if should you have any questions, please don’t hesitate to contact us at the company. All right. Have a good night.
Operator: This concludes today’s conference call. Thank you for participating. You may now disconnect.
