CymaBay Therapeutics (CBAY) Plans for Second MBX-8025 Phase 2 in Primary Biliary Cholangitis

October 5, 2016 8:27 AM EDT

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CymaBay Therapeutics, Inc. (Nasdaq: CBAY) announced that after receiving input from the U.S. Food and Drug Administration (FDA), it has determined the next step in the development of MBX-8025 in subjects with primary biliary cholangitis (PBC). MBX-8025 is an orally administered potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist.

An initial Phase 2 study of MBX-8025 in subjects with primary biliary cholangitis was terminated earlier this year when proof-of-concept was demonstrated by marked improvements in biochemical markers of cholestasis, including alkaline phosphatase (ALP), a surrogate biomarker that has been linked to clinical outcomes in PBC. The study also identified a treatment emergent signal of transaminase elevations. The magnitude of the ALP reductions in the study suggested that lower doses may retain ALP reductions while avoiding transaminase elevations. After discussions with regulatory authorities, the company will be initiating a second Phase 2 study that will investigate lower doses of MBX-8025 in subjects with PBC to optimize the response. Initiation of the study is expected by year end 2016.

“We are very pleased that the next steps in the development of MBX-8025 for PBC are now clearly defined,” said Harold Van Wart, Ph.D., President and Chief Executive Officer of CymaBay Therapeutics. “Having established clinical proof-of-concept, we can now focus on dose selection to optimize the response in the next study. Based on the magnitude of the ALP lowering observed in our earlier Phase 2 study and the fact that MBX-8025 does not appear to cause pruritus, we are eager to explore a lower dose range.”

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