The study is evaluating its seladelpar in patients with primary biliary cholangitis with enrollment to be completed by end of November.
CymaBay Therapeutics (NASDAQ:CBAY) has announced that it has reached its target goal of 240 patients in its ENHANCE Phase 3 clinical trial in patients with primary biliary cholangitis (PBC).
As quoted in the press release:
CymaBay is on track to complete full enrollment by the end of November.
With more than 240 patients enrolled, ENHANCE is CymaBay’s lead regulatory registration study evaluating the safety and efficacy of its investigational drug, seladelpar, for patients already diagnosed with PBC who have been using ursodeoxycholic acid (also known as UDCA or ursodiol), but have not achieved the recommended treatment goal or cannot tolerate UDCA. ENHANCE is a 52-week, placebo-controlled, randomized study conducted in over 20 countries.
“We thank our investigators, their staff, and patients worldwide for their support in achieving today’s milestone for this landmark study in PBC. 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,” stated Sujal Shah, President and Chief Executive Officer of CymaBay Therapeutics. “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.”