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: Joe Thome - TD Cowen - Analyst
: Great. And obviously reaffirmed guidance for the Phase 3 data this year, but obviously the question we always get is on enrollment. I guess, what
are you seeing in terms of enrollment overall in focal onset epilepsy? And maybe as it relates to the X-TOLE2 study as much as you can kind of
comment on that.
Question: Joe Thome - TD Cowen - Analyst
: Great. Obviously, you saw the very strong Phase 2 results. What are you looking for from an efficacy standpoint in the Phase 3? Do you just need
to hit stats on the primary? And can you kind of walk us through what the powering assumptions were when you designed the study?
Question: Joe Thome - TD Cowen - Analyst
: Perfect. And maybe on that point, that is what our KOLs kind of bring up is they want a drug that's efficacious, low or no titration, once daily dosing,
and plays well with others. I guess maybe on what you're seeing in XCOPRI, where does that not play well in terms of tolerability? What will you
be looking for in terms of tolerability? Maybe that folds into maybe what you've seen with the AES data. I know there are some interesting results
on long-term Phase 2 data and kind of how azetukalner plays with other mechanisms.
Question: Joe Thome - TD Cowen - Analyst
: And maybe can you talk a little bit about your go-to-market strategy? How are you initially going to target that? And maybe for Sherry, how does
that fall on the backdrop of your current funding dynamic?
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
MARCH 04, 2025 / 3:30PM, XENE.OQ - Xenon Pharmaceuticals Inc at TD Cowen Healthcare Conference
Question: Joe Thome - TD Cowen - Analyst
: Perfect. Maybe we'll jump over the neuropsychiatry side of things. But you released the Phase 2 data a little over a year ago now for MDD, didn't
quite hit the mattress, but you did show benefit on the HAM-D. Can you kind of walk us through maybe what about that measure. Maybe lends
itself a little bit more to azetukalner's Kv7 mechanism and what led you to kind of flipping that to be the primary endpoint of your Phase 3 program.
Question: Joe Thome - TD Cowen - Analyst
: Perfect. Yeah, and our neuropsychiatry panel, KOL panel said that for you guys this morning that you just have to hit and then get the drug on the
market, and they'll use it. So I think that's good to see. They were also supportive of Kv7 in bipolar depression, and you indicated last week that
you're going to start two Phase 3 studies in bipolar depression. Can you maybe go into a little bit of detail why you like the Kv7 mechanism of
bipolar depression? And obviously, we've seen others in the space look at the other side, bipolar mania. Why depression and not mania for you?
Question: Joe Thome - TD Cowen - Analyst
: Perfect. And you've also indicated that you do have some other Kv7 drugs that are in pre-clinical development. How did you make the decision to
go forward in bipolar depression with azetukalner versus maybe some of these other agents?
Question: Joe Thome - TD Cowen - Analyst
: Maybe on pain, the last couple of minutes here, you have the Nav1.7 and you have the Kv7. How are you thinking about prioritization of those for
pain and what should we expect this year in terms of advancement of those programs?
Question: Joe Thome - TD Cowen - Analyst
: Awesome. Well, that I think we're out of time, but a lot to look forward to this year. Thank you for joining us.
|