CymaBay initiates Phase 3 study of Seladelpar

CymaBay announced the initiation of its 52-week, placebo-controlled, randomized, Phase 3 IDEAL study. The study aims to enroll 75 patients with PBC who have an incomplete response or intolerance to ursodeoxycholic acid in each case with ALP greater than the upper limit of normal 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 at 6 months for patients with moderate to severe symptoms at baseline. PBC is a rare, chronic inflammatory liver disease primarily affecting women over the age of 40. PBC is characterized by impaired bile flow and the accumulation of toxic bile acids in the liver, leading to inflammation and destruction of the bile ducts within the liver and causing increased levels of ALP and total bilirubin.