The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Paul Matteis - Stifel - Analyst
: Great. Thanks so much. Can you hear me?
Question: Paul Matteis - Stifel - Analyst
: Okay, excellent. Thank you. Appreciate the presentation. As it relates to the analysis of LIFT, can you talk about the different options that are on
the table? And I guess, how much can you learn from blinded data? Can you really learn all that much that can give you real conviction? Or do you,
ultimately, think that you might need to unblind the trial to get a better sense?
And I guess, maybe just to that point, given that half of the patients are on a cholinesterase inhibitor in LIFT, it would seem like the intent-to-treat
analysis in that study is going to be challenged based on these data. So why not just unblind the data? What would be the downside there?
Question: Paul Matteis - Stifel - Analyst
: Okay, thanks. And maybe one other question on the subgroup analysis. It does seem like some of the difference between the overall population
and the non-cholinesterase inhibitors subgroup is driven by how differently placebo performs in that subgroup and that small number of patients
and their ADAS-Cog decline and P300 increase.
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Question: Paul Matteis - Stifel - Analyst
: Okay. Can I just -- one last quick thing? What do you plan to articulate when -- as it relates to LIFT, what should we be expecting?
Question: Paul Matteis - Stifel - Analyst
: Okay, okay. All right. Thank you very much. Appreciate it.
Question: Andrew Tsai - Jefferies - Analyst
: Okay. Thanks, guys, for hosting this. Appreciate it.
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Question: Andrew Tsai - Jefferies - Analyst
: Great. And a follow-up to Paul's question. How exactly are you thinking about optimizing LIFT-AD? I mean, before, one of the possibilities is possibly
rearranging the endpoints, but that might not make sense at this juncture. So what exactly could be some of the other possible options at this
juncture?
Question: Andrew Tsai - Jefferies - Analyst
: I see. And so on that premise, does it make sense -- sorry, this is my last question -- does it make sense to talk to the FDA now before LIFT-AD reads
out to see if you can get alignment around that idea? (multiple speakers)
Question: Andrew Tsai - Jefferies - Analyst
: Thank you, guys. Thanks for hosting us.
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Good morning, everyone. On the monotherapy arm, do we know if these patients are primarily treatment naive for other acetylcholinesterase
inhibitors, or are they patients who can step through that? And what are the implications both for the trial and then as well kind of down the road,
if you were to see an effect in the monotherapy group?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: And do you have a sense for what portion has been treated versus what patients had not been treated with cholinergics before?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay, helpful. And then what are the implications for potential clinical trial timelines that you do to [certainly reach] for patients in monotherapy,
given you've already enrolled a significant portion of the trial?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay. Thank you.
Question: Jason Butler - JMP Securities - Analyst
: Great. Thanks for taking the questions. Just -- have you looked at, in the monotherapy patients, the baseline characteristics? And were there any
differences in baseline characteristics between monotherapy and patients that are on acetylcholinesterase inhibitors?
And then secondly, can you give us a sense of what proportion of the 17 patients in the monotherapy subgroup showed an improvement in P300?
I think that was one of the things from the Phase 1b is that all seven patients improved. Was that -- just -- and if you can't give us a precise number,
an overall sense of what proportion showed improvement? Thanks.
Question: Jason Butler - JMP Securities - Analyst
: Okay, great. And I know I'm asking you to speculate a little bit here. But have you thought about mechanistically why fosgo would have benefit as
a monotherapy and not on top of acetylcholinesterase inhibitors?
And I know the patient numbers are getting small here. But are you able to look at prior response to the, for example, donepezil and whether that's
predictive of -- that if you come off, if you respond to another therapy -- I get it. It's speculation, but any thoughts you have on mechanistic rationale
would be appreciated.
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Great. Thanks for taking the questions.
Question: Tom Shrader - BTIG - Analyst
: There we go. Well, thanks for the update. I'm not sure I would've predicted this, but I can understand it in retrospect.
I'd just reiterate, because most of the questions have been asked, if you were to unblind the Phase 3 now, you'd have about 100 patients who've
completed monotherapy. Is that right? So you get a pretty definitive read as to whether today's data are real.
Question: Tom Shrader - BTIG - Analyst
: Okay. All right. That's kind of what I had.
One another quick question. Do you expect DSMBs will immediately stop enrolling combination therapy? How quickly do you have to let them
know because you have more than -- you have a slightly confounding effect?
Question: Tom Shrader - BTIG - Analyst
: Okay, great. Thank you.
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