Seladelpar for PBC moves to phase 3 following positive safety results
CymaBay Therapeutics achieved its targeted patient enrollment for the EHANCE trial, a phase 3 study of seladelpar for primary biliary cholangitis, and that the company is on track to complete full enrollment by the end of November.
“Reaching the recruitment goal of our phase 3 study ahead of schedule underscores the enormous unmet need for new treatment options in this serious, chronic liver disease,” Sujal Shah, president and CEO of CymaBay Therapeutics, said in the press release. “I am proud of our team’s efforts, which are focused every day on delivering for patients and their families. Through ENHANCE, our goal is to find a new treatment alternative to help people living with PBC.”
The 240 enrolled patients have been previously diagnosed with PBC and received treatment with ursodeoxycholic acid but had not achieved the recommended treatment goal or could not tolerate continued treatment with UDCA.
The 52-week randomized control trial follows positive pharmacokinetic results from a phase 2 study of seladelpar in patients with PBC with or without cirrhosis in which investigators found no accumulation after repeated dosing and treatment appeared safe and well-tolerated.
CymaBay will present additional phase 2 data at this year’s The Liver Meeting in Boston.