CymaBay announces publication of safety, efficacy results of seladelpar

CymaBay Therapeutics announced that two-year safety and efficacy results of seladelpar for primary biliary cholangitis have been published in Alimentary Pharmacology & Therapeutics: Open-label, clinical trial extension: Two-year safety and efficacy results of seladelpar in patients with primary biliary cholangitis This open-label, international, long-term extension study, evaluated the efficacy and safety of seladelpar a potent, selective, orally active PPARdelta agonist, or delpar, through 2 years of treatment in patients with PBC. Patients with PBC were eligible to enroll in this long-term extension study if they had successfully completed a prior study of seladelpar. Adults from the lead-in studies had enrolled having a diagnosis of PBC after persistent elevation in the cholestatic marker alkaline phosphatase despite current or prior treatment with first-line ursodeoxycholic acid. The objectives were to evaluate the long-term safety, tolerability, and efficacy of seladelpar at 5 mg and 10 mg once daily throughout 2-years. A composite of alkaline phosphatase and bilirubin previously accepted for regulatory approval served as an endpoint. The composite was achieved by 63% and 79% of patients after one and two years, respectively. In addition, ALP normalization was achieved in 23% and 42% in patients at one and two years, respectively. Over two years, there were sustained reductions in ALT and AST, recognized markers of liver injury. Seladelpar appeared safe and well-tolerated. In the study long-term treatment with seladelpar resulted in continued improvement in markers of cholestasis and liver injury in the second year of treatment.