CymaBay Therapeutics, Inc. (NASDAQ:CBAY) Q4 2022 Earnings Call Transcript

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I think for us, the excitement is really the opportunity to meet with all these leaders and understand where the field is going. And I think you’re going to see a strong desire to adjust treatment guidelines. There was just a paper in alimentary pharmacology and therapeutics from the group looking at the globe score and normal alkaline phosphatase levels, recommending that normal levels should be the goal. So, this is the second important paper that’s been published that’s supporting this.

Sujal Shah: The only other thing I’d add, Kristen is, not just at this meeting for the 10-year anniversary of global, but I think increasingly in a lot of our interactions at advisory panels and throughout the course of this year, the discussion around real world data and generating real world evidence. And so, this is another area in addition to thinking about seladelpar specific impacts on disease burden, quality of life, and symptom burden for patients. We’re committed also to thinking about the opportunities we have to generate real world data and real world evidence as seladelpar progresses potentially towards registration and commercialization if we’re successful in the program. So, these are also topics I think that we expect to have continued discussion around at this meeting and others.

Kristen Kluska: Thank you for that. And with the milestone of now having over 200 patients in ASSURE, do you have an update in metric, excuse me, in terms of the number of patients that have passed 1, 2 and 3 years on drugs? Thank you again.

Sujal Shah: I’ll say this. You know ASSURE as it was set up, first brought back patients that had previously been on seladelpar. I think at least 50 of which that were potentially eligible that had been on treatment for at least 2 years from our prior clinical studies, north of 100 patients that had been on the drug for a year and then various time points even earlier from our prior ENHANZE study. So, it’s a bit discontinuous for some of those patients as we had stopped and then restarted the program. And so by the time we started ASSURE, I think as Chuck had mentioned, there’s a good number of patients certainly with over a year of experience and even two years, particularly as you combine those two different periods for patients.

We now of course have patients rolling over from RESPONSE. So, at the time that we would expect effectively to look to file and register seladelpar, successful in response. There are many of those patients that are going to be even to the one-year time point and beyond as well, but we’ve not specifically provided numbers. I simply would tell you that when we think about the only other approved second-line treatment today, obeticholic acid, the numbers of patient exposures will have in totality, as well as those number of patients to one-year and even two-years of treatment, we believe will be even greater than the numbers that were there of obeticholic acid when it was registered.

Kristen Kluska: Great. Thank you again.

Sujal Shah: Thank you.

Operator: And the next question comes from the line of Patrick Dolezal with LifeSci Capital. Please proceed with your question.

Unidentified Analyst: This is on for Patrick. Just a couple from us. As it relates to pruritus, seladelpar has shown a pretty clear positive signal. Just curious if you have any evolving thoughts on the etiology of pruritus in PBC and seladelpar’s ability to modulate specific . Specifically, we’ve seen data on C4 and bile acids, but have you looked at autotaxin, IL-31, or others?

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