CymaBay initiates AFFIRM, a Phase 3b/4 study evaluating seladelpar

CymaBay Therapeutics announced the initiation of AFFIRM, a randomized, placebo-controlled confirmatory study to evaluate the effect of seladelpar on clinical outcomes in patients with compensated cirrhosis due to primary biliary cholangitis, PBC. The AFFIRM study is planned to enroll approximately 192 patients with PBC who have compensated cirrhosis based on prespecified clinical criteria. Patients will be randomly assigned using a 2:1 ratio to oral, once daily seladelpar or placebo for a fixed duration of three years. The primary outcome measure is the time from start of treatment to the first occurence of clinical events. Additional key outcomes include overall survival, liver transplant-free survival, and time to hospitalization for serious liver-related events. Charles McWherter, Ph.D., Chief Scientific Officer and President of Research and Development at CymaBay, stated, “The AFFIRM study was initiated to characterize the efficacy and safety of seladelpar in a PBC population with advanced disease. It is designed to fulfill post-marketing requirements of the accelerated approval pathway for seladelpar to confirm its benefit on clinical outcomes. Over the past few years, we have had significant interactions with regulators to develop a study in the backdrop of many known operational and ethical challenges in conducting a placebo-controlled long-term outcomes study. We selected this population and design to establish the effect of seladelpar on clinical outcomes. We remain fully committed to meeting our scientific and regulatory commitments while prioritizing the health of people living with PBC.”