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).
CymaBay’s Seladelpar Hits Three Endpoints In Phase III PBC Study
Seladelpar may threaten an entrenched second-line therapy, Intercept’s Ocaliva, with better efficacy, based on benefits demonstrated in the pivotal RESPONSE trial.