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: Jason Gerberry - BofA Global Research - Analyst
: OK, great. So maybe we'll start with epilepsy and with putting your clinical data aside for a moment, just kind of curious if you were asked a question
like, what do you think makes focal onset, right? Like a good market in terms of launching a new drug given, you've got a number of generic
alternatives available for you. And so that's always going to beg the question. Is this a space that's going to reward innovation. So maybe I'll start
there and then I've got some follow ups.
Question: Jason Gerberry - BofA Global Research - Analyst
: How would you -- a lot of people focus on the scope relaunch and as a learning more than anything, right. Yeah, I think they're, what, in year three
or four, I believe that they launched during COVID. So there's all sorts of, I guess caveats here. But if you look at that as a proxy, right? For the market,
where new innovative things, things that I typically hear about [expobi] is good on efficacy, good on driving seizure freedom, not the easiest to
onboard for patients.
And so I guess I'd love to get your perspective on that as sort of like a proxy or something that you learn from as you think about go to market.
Question: Jason Gerberry - BofA Global Research - Analyst
: Yeah, I mean, I know that over the years you've talked about, based on the profile you've seen in X-TOLE to the potential to be kind of first brand,
right? And that's third line maybe mainly, but there's also some second line utilization for a first brand.
But then I think more recently you've talked about the mood benefit possibly being a swing factor that could facilitate even more early line use.
So, how does that, I guess as long as you have a positive pivotal trial, you feel like there's a knock on effect that that could drive earlier line as defined
by second line or just broader use with physicians, knowing they want to have that adequate coverage again mood given the high level of
comorbidity.
Question: Jason Gerberry - BofA Global Research - Analyst
: Ok. And then, thinking about, if you're able to directionally, see consistent results with X-TOLE2, when we think about sort of the ultimate regulatory
review and product labeling considerations, where do you stand on whether you think retinal exams at either treatment, initiation or post treatment
would be potentially required a based on any kind of like a predecessor molecule, even if you run your trial and you have this long term follow up
and you don't see anything. I guess is there a theoretical concern? How do you think about that or frame that for investors?
Question: Jason Gerberry - BofA Global Research - Analyst
: And then in terms of just trial enrollment execution, things like that, you there are competitors running late stage trials as well. It doesn't appear
that you have a high degree of trial site overlap. And so I imagine since you met with investors in early September, not a lot has changed and that
you're accruing patients in a similar time frame, your timelines for topline haven't changed, but just anything worth acknowledging or commenting
on there.
Question: Jason Gerberry - BofA Global Research - Analyst
: Okay. Maybe shifting gears to MDD. I was speaking to, I guess a CEO from another company this morning who said, well, if I was starting a CNS
business, I may not start with psychiatry because of some of the just the known challenges, right? In it was more from a commercial standpoint,
right? Like the cost, the gross and net all those dynamics, the number of competitive alternatives.
So as you look at this space, why do you feel like it's attractive for a novel MOA? I know there's a lot of excitement also for Kappa opioids. So there
are new approaches and people are investing and seeing success with late line options.
Question: Jason Gerberry - BofA Global Research - Analyst
: So when I talk to psychiatrist, what never comes up is comparison of these different drugs on their efficacy effect size deltas. It's just doesn't strike
me as like the most data driven on the efficacy side. It almost feels like just give me something that's static it's a novel mechanism that certainly
helps a lot of sensitivity around tolerability in the MDD space.
And so that's my preamble to the question, right, which is that you decided to advance the 20 milligrams dose probably a little higher than we
initially thought you might go with when you were still in Phase 2. And so I guess just like your comfort level that what we saw in Phase 2 was
representative of this dose.
And maybe, look your epilepsy data you generated with 20 milligrams is compounded by the fact that it's basically there's a lot of other background
meds. So it's hard to tease out and then you have the bedtime dosing which presumably mitigates some of the cmax related adverse events. And
so maybe that's the answer, but I wanted to kind of leave it to you to maybe frame that
Question: Jason Gerberry - BofA Global Research - Analyst
: OKay. And maybe shifting gears to the early stage pipeline, sodium channel NAV1.7. And I know that the idea would be to perhaps file an IND
sometime in 2025. And so candidate selection is sort of where you're at if I am gathering sort of the bread comes correctly. So this mechanism,
NAV1.7 specifically has had some attrition out there.
Historically, selectivity has been sort of a goal, even though I guess with [pfizer's] [Sulfon], that's all I can't pronounce it correctly had run into some
issues. So I guess just how you're thinking about differentiating from those other approaches, be it either finding site or other properties that you
feel like can really optimize this, this target?
Question: Jason Gerberry - BofA Global Research - Analyst
: Is the in house view that, when it comes to the topic of, does it make sense to combine NAV1.7, 1.8 approaches that perhaps we don't need to do
that or a curious, we'll follow the developments in that space. But at the moment, our base case is that we may not need to combine the two
approaches.
Question: Jason Gerberry - BofA Global Research - Analyst
: Ok. Well, we're up against time here, but I really appreciate, you know, both of you guys spending a lot of time with us and sharing your perspectives
on some of the latest developments at Xenon. And so with that, we can wrap up the call.
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OCTOBER 07, 2024 / 3:40PM, XENE.OQ - Xenon Pharmaceuticals Inc at Bank of America CNS Therapeutics
Virtual Conference
Question: Jason Gerberry - BofA Global Research - Analyst
: It. All right. Thanks guys.
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