CymaBay determines next step in MBX-8025 process

CymaBay Therapeutics has determined the next course for the development of MBX-8025 in patients with primary biliary cholangitis (PBC) after the U.S. Food and Drug Administration (FDA) gave the company input on the process.

“We are very pleased that the next steps in the development of MBX-8025 for PBC are now clearly defined,” CymaBay Therapeutics President and CEO Harold Van Wart said. “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.”

MBX-8025 is a receptor delta agonist that is activated by peroxisome proliferator and is administered to patients orally. The MBX-8025 Phase 2 clinical trial, which was conducted on patients that have PBC, was cancelled when proof-of-concept was confirmed when cholestasis biochemical markers were improved including alhaline phosphatase (ALP).

The trial also showed an emerging signal in treatment of elevated levels of transaminase. The number of reductions in ALP showed that a lower dose might maintain the result.