CymaBay Initiates AFFIRM, a Phase 3b/4 Study Evaluating the Effect of Seladelpar on Clinical Outcomes in Patients with Cirrhosis due to Primary Biliary Cholangitis
AFFIRM is a unique event-driven, fixed-duration design intended to reduce the challenges for patient participation
Data will be used to support post-marketing regulatory requirements for seladelpar’s accelerated approval pathway
NEWARK, Calif., Sept. 21, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today 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 (Child-Pugh A or Child-Pugh B) 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 (all-cause death, liver transplant, hospitalization for other serious liver-related events, and progression to Child-Pugh C decompensated cirrhosis). 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.”
“The goal of therapy in patients with PBC is to prevent progression to end-stage liver disease and liver failure, however, carrying out placebo controlled outcomes trials is challenging due to the long natural history of PBC. I am pleased to learn that the AFFIRM study will aim to confirm the benefit of seladelpar in patients with PBC over a three year period, which is the shortest timeframe we have seen to date for a confirmatory trial,” said Dr. Kris V. Kowdley, Director of Liver Institute Northwest, and Professr at the Elson S. Floyd College of Medicine, Washington State University.
For additional information about CymaBay visit www.cymabay.com.
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