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: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Great. Thanks, Lonnel, and we'll just give it a moment for your colleagues' video to come back on. And while we're doing that, I would just remind
folks that if you want to ask a question, you can use the blue button on your screen to send questions to the portal, and I can ask them from
management.
But maybe first, just to start out, just for a little context, how does the potential indication that the FDA says that SCORED and SOLOIST will support,
how does that indication compare to the -- for Farxiga label and the Jardiance label?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Okay. Great. Now you talked about in your 2021 objectives, both the collaboration and the NDA filing for sotagliflozin in heart failure. Will you file
on your own? Or will you wait for a partnership before doing that?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: All right. And what type of deal structure would you be most interested in as you think about a potential partnership?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Great. And to be clear, while you're -- today, announcing a feedback on your ability to file for a heart failure indication. Is there any reason to think
you would not be able to secure an approval for improving glycemic control in type 2 diabetes?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Got it. And if a partner wanted to also get a label in type 2 diabetes, would the regulatory review for each of those indications have to happen in
sequence or can it happen concurrently?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Okay. Got it. And I was noticing that the other -- that the SGLT2 labels kind of specifically say not for treatment of type 1 diabetes as a limitation
[of use]. Have you heard any more or talked any more to the FDA about the path forward in type 1?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Great. You also talked about the -- some of the epidemiology data as it relates to heart failure and the kind of potential indication you could secure
with sotagliflozin. Can you put some dollars around that? So what do you see as the peak sales opportunity? And/or launching with kind of the
cardiovascular angle first, do you think of pricing is potentially different relative to the products that were originally approved for glycemic lowering?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Okay. Maybe we can switch to your favorite product. Is it still your favorite product?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: All right. So as we think about these Phase II readouts coming up, talk to me about what represents a win in those trials? What's the bar you want
to hit on a placebo-adjusted basis for the change from baseline in average daily pain score?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Okay. And just to go back, did you say your power to detect less than a 1 point difference?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: And is that clinically meaningful to have less than a 1 point difference?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Can you talk a little bit more about the mechanism of action for this product? And whether it addresses centralized pain that might be driving this
symptomatology in patients with more advanced DPN?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Okay. Got it. And I know placebo response is frequently an issue in pain studies. Can you talk a little bit more about your strategies for controlling
the placebo response here? Lonnel, you were emphasizing kind of patient selection. But maybe specifically, what elements of patient selection
and what other strategies are you using to avoid a high placebo response?
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JANUARY 14, 2021 / 7:50PM, LXRX.OQ - Lexicon Pharmaceuticals Inc at JPMorgan Healthcare Conference
(Virtual)
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: What about things like concomitant medications?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Got it. And it looks like on clinicaltrials.gov, one of the inclusion criteria is pain from DPN present for at least 6 months. Is 6 months long enough to
be sort of not naive to their condition?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Right. So with these measures that you're taking on enrollment, is the greenfield rate tracking in line with your expectations?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Okay. Got it. So we're just about out of time, so we'll wrap it up there. But thanks, everyone, for tuning in and thanks to the Lexicon team.
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