CymaBay Initiates IDEAL, a Phase 3 Placebo-Controlled, Randomized Study of Seladelpar in Patients with Primary Biliary Cholangitis and Incomplete Control of Alkaline Phosphatase

valuates seladelpar 10 mg vs. placebo for alkaline phosphatase normalization at 52 weeks

Patients enroll with alkaline phosphatase levels between 1- and 1.67-times upper limit of normal

Excerpt from the Press Release:

NEWARK, Calif., Aug. 10, 2023 /PRNewswire/ — CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases, today announced the initiation of its 52-week, placebo-controlled, randomized, Phase 3 study — “Intended to Determine the Effects of seladelpar on normalization of Alkaline phosphatase (ALP) Levels in subjects with Primary Biliary Cholangitis (PBC)” (IDEAL).

The IDEAL study aims to enroll 75 patients with PBC who have an incomplete response or intolerance to ursodeoxycholic acid (UDCA), in each case with ALP greater than the upper limit of normal (ULN) but less than 1.67xULN, and total bilirubin less than or equal to 2xULN. Patients will be randomly assigned using a 2:1 ratio to oral, once daily seladelpar 10 mg or placebo. The primary outcome measure is the normalization of ALP at 52 weeks.

Additional key outcomes evaluating efficacy include the percent change from baseline in ALP at 52 weeks and the level of self-reported pruritus (itch) at 6 months for patients with moderate to severe symptoms at baseline, assessed by a numerical rating scale (NRS) and recorded by electronic diary.

Charles McWherter, Ph.D., Chief Scientific Officer and President of Research and Development at CymaBay, stated, “CymaBay has a long-standing commitment to advancing patient care.

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