The following is excerpted from the question-and-answer section of the transcript.
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Question: Andrew Tsai - Jefferies - Analyst
:
Question: Andrew Tsai - Jefferies - Analyst
: Got it. And just a reference point would be helpful on these harder endpoints on ADAS-Cog, CGIC, ADL. What do the approved drugs for mild-moderate
Alzheimer's show at six months for these three efficacy endpoints?
Question: Andrew Tsai - Jefferies - Analyst
: Okay. And then my last question is, you shared some interesting AD/PD data update on ACT-AD. I think 50% to 60% of your patients in this study
are on acetylcholinesterase inhibitor. So 40% are, I believe, treatment-naive. I believe that naturally the old studies in the past probably were done
in naive patients. So here, if 50% to 60% of patients are on a combo therapy, how does that dynamic affect both the placebo and the drug arm on
ADAS-Cog? Thanks.
Question: Andrew Tsai - Jefferies - Analyst
: Very good. Thanks for all the color.
Question: Paul Matteis - Stifel - Analyst
: Great. Thanks so much for the detail you're offering. I wanted to clarify a couple of things, if I might. So one is, I guess for LIFT, the hope here is that
you hit on both cognition and function, is that right?
Is that still your assumption that ADAS-Cog alone would not be enough to get registered? And if that's right, how much flexibility do you see on
which functional scale you need to succeed on? And how much time do you have, I guess, to pre-specify which you're using in the Global Statistical
Test?
And then the one last thing I just wanted to ask out of curiosity. Not sure if you're willing to disclose, but just when you look at the baseline data
in ACT, right? You did a number of different baseline data cuts which is appreciated. When you look at patients across disease severity at baseline,
do you see any association with their baseline P300 latency? Thanks so much.
Question: Paul Matteis - Stifel - Analyst
: Yeah. No. Thanks, Hans. I was just kind of making sure that you agree with the premise that you likely need to hit cleanly on both the cognitive and
functional endpoint for registration. And there is one, I think it's Mark's prepared remarks surrounding sharing ADAS-Cog in the top line, but it
doesn't sound like you're going to share any functional scales. I'm honestly a little bit sure why that is, but yeah, maybe you can just give any more
color would be great.
Question: Paul Matteis - Stifel - Analyst
: Yeah. Totally understood. Thanks very much.
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Hey. Good afternoon, everyone. I just had one quick follow up. In terms of the ACT-AD study, have you taken a blinded look at the data? And if so,
is there any color that you can provide on that?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: And then, I think maybe just an enrollment update on LIFT. Since you announced the expansion, I'm just curious if there's -- I know part of it that
was used are really good enrollment and then we had Omicron. So I'm curious if you could provide any color on the pace of enrollment in LIFT and
actually the thoughts in the data timing there?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: And will you announce that when you hit enrollment [positions], or is that some data you won't disclose?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Great. Thank you so much.
Question: Jason Butler - JMP Securities - Analyst
: Hey. Thanks for taking the questions. Just one on the cognition trends you look for in ACT. Mark, I think you said you're not going to show the
graphs, but just how should we think about the potential time course of impact on cognition here versus the relatively rapid effects you see on
P300, also on P300 in the Phase 1 trial. The correlation there between P300 and cognition timelines for other drugs, is that relevant here?
Question: Jason Butler - JMP Securities - Analyst
: Got it. And then just a couple of quick questions on the SHAPE trial.
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Could you just maybe remind us of the mechanistic rationale in PDD and DLB? Do you see the same kind of dysfunction in the HGF/MET system
that you see in Alzheimer's patients? And then I think it's pretty clear what potential impacts of the ACT results on the LIFT trial, but are there any
changes that you would consider making to the SHAPE trial based on the results you get from ACT? Thanks.
Question: Jason Butler - JMP Securities - Analyst
: Okay, great. That's helpful. Thanks for taking the questions.
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