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, Scott, for that presentation. (Operator Instructions)
Maybe I can start with paltusotine. You described your Phase II data in acromegaly. I guess, is there anything specific you would call out about the
profile that gives you confidence in the success of the ongoing Phase IIIs?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Got it. And you talked about the designs of the PATHFNDR trials. But can you also describe the powering assumptions for each of those studies?
Why is the PATHFNDR-2 study in the treatment-naive patients smaller than of PATHFNDR-1, switching from standard of care?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Yes, thanks. How many patients do you expect might need to titrate up to the 60-milligram dose in Phase III, given it kind of seems like the
40-milligram dose should generally be adequate? And how will physicians make that decision?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: And when do you expect to reach full enrollment in the trials? Is that something you'll announce? And similarly, when could we see data? And
which study would you expect to read out first?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Got it. And what's the size of the commercial opportunity in acromegaly? I think one of your slides flashed up the revenue for the injectable products,
but I think that includes NETs in some instances. So what about the acromegaly market in particular?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Got it. So that's a good pivot into next. Can you elaborate a little bit more on your clinical development strategy in that setting? And I guess to the
extent you think that NETs are undertreated with the injectable products, what do you think the commercial revenue opportunity is for that segment
and maybe as well as the slice that is carcinoid syndrome?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Great. Maybe we can switch gears and talk about 4894. What levels of cortisol reduction do you expect to see in the MAD data?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: And I hear what you're saying on that. But just to push back on that a little bit, I think if you showed a very low percent change, folks might not be
as optimistic about normalization in patients down the line. So is there some kind of minimum change that you would want to see? I think Alan
said PD that was the same. And I think maybe he meant the same as what you saw in a single ascending dose?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Okay. Great. Well, look forward to that update soon, and we are out of time. So we've got to leave it there. But thank you for the presentation and
the thoughtful Q&A. And thanks, everyone, for listening in.
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JANUARY 12, 2022 / 9:30PM, CRNX.OQ - Crinetics Pharmaceuticals Inc at JPMorgan Healthcare Conference
(Virtual)
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