CymaBay’s Seladelpar Hits Three Endpoints In Phase III PBC Study

 
• By Joseph Haas
  
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Seladelpar may threaten an entrenched second-line therapy, Intercept’s Ocaliva, with better efficacy, based on benefits demonstrated in the pivotal RESPONSE trial.

CymaBay Therapeutics, Inc. reported data that analysts called nearly a best-case scenario across three key endpoints for its PPAR delta agonist seladelpar in primary biliary cholangitis (PBC) on 7 September, but a few questions persist about a higher-than-expected placebo response on the Phase III trial’s primary endpoint. Still, the broad expectation is that seladelpar likely will be approved for second-line treatment of PBC and prove strong competition in that setting to Intercept Pharmaceuticals, Inc.’s Ocaliva (obeticholic acid).

Initially, CymaBay was developing seladelpar as one of several PPAR agonists for non-alcoholic steatohepatitis, but missed its primary endpoint of...

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