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: Andrew Tsai - Jefferies - Analyst
: Great. Thank you. So today, I wanted to spend much of the time on MDD, because I do think it is a meaningful catalyst for you guys later this year.
But maybe some kind of check the box type of questions for your epilepsy programs first. So like you said Sherry, you traditionally had a strong
presence at AES traditionally. What can we expect to see specifically from the Phase 2b X- TOLE? What kind of update?
Question: Andrew Tsai - Jefferies - Analyst
: Great. And so now you have three ongoing Phase 3 studies in epilepsy. The natural question would be, when do you think you'll be prepared to
give us some type of guidance on the top-line data for X-TOLE2, one of your two focal epilepsy studies, as well as PGTCS?
Question: Andrew Tsai - Jefferies - Analyst
: Okay. We look forward to that. In addition to the Phase 3, I think we generally understand you're powered, highly powered, to show a 15% delta
on the primary endpoint. But how about the week-one end point where you're trying to elucidate whether XEN1101 does have rapid-acting activity?
What do we want to see there, drug versus placebo? And let's just say it did -- it didn't meet your criteria. How would it be incorporated in the label
-- for instance, with the front-page label claims a fast acting treatment for epilepsy, for instance?
Question: Andrew Tsai - Jefferies - Analyst
: Great. And then in the meantime, you also have the PGTCS study going on Phase 3. Just really quickly, how did you power that study -- high-dose
versus placebo?
Question: Andrew Tsai - Jefferies - Analyst
: Interesting. Okay. That's very helpful. Thank you. And so, now let's move on to MDD. You do have data, I believe, Q4. So can you walk us through
the timing of, I believe, the last patient will be screened this month to the top-line release? Walk us through the study design and data cleaning
and all that.
Question: Andrew Tsai - Jefferies - Analyst
: Very good. And what do you plan at this juncture to share in the top-line release in Q4? How detailed of a readout can we expect to see?
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JUNE 07, 2023 / 1:30PM, XENE.OQ - Xenon Pharmaceuticals Inc at Jefferies Healthcare Conference
Question: Andrew Tsai - Jefferies - Analyst
: Great. And placebo, when we think about depression, placebo is one of the key risks. So walk us through how you've tried to mitigate or curve a
high placebo response?
Question: Andrew Tsai - Jefferies - Analyst
: And how have screen failure rates looked, let's say, compared to your epilepsy X-TOLE study?
Question: Andrew Tsai - Jefferies - Analyst
: Great. That's great to hear. And you mentioned how you would plan to share next steps for the program in parallel to a top-line release. So what
are the inputs? Describe what next steps could be? And what are the inputs that drives your decision one way or the other?
Question: Andrew Tsai - Jefferies - Analyst
: Okay. Very good. I should have asked this earlier, but in the last minute we have -- your powering and then your confidence in MDD to succeed. I
should have asked early on.
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