CymaBay Announces Positive Results From Phase 3 Study Of Seladelpar In Primary Biliary Cholangitis

(RTTNews) - CymaBay Therapeutics Inc. (CBAY) announced positive results from its Phase 3 pivotal RESPONSE study of seladelpar in primary biliary cholangitis.

In Thursday pre-market trade, CBAY was trading at $16.73 up $2.90 or 20.98%.

The study evaluated the safety and efficacy of seladelpar, a potent, selective, orally active delpar or PPARd agonist, in development for the treatment of adult patients with primary biliary cholangitis (PBC). The registration trial achieved the primary and all key secondary endpoints and supports advancement to regulatory discussions and filing for regulatory approval with the U.S. Food and Drug Administration, the Medicines and Healthcare products Regulatory Agency, and the European Medicines Agency.

Primary composite endpoint at 12 months of serum alkaline phosphatase and bilirubin was met by 61.7% of patients treated with seladelpar 10 mg compared to 20.0% of placebo treated patients.

Normalization of alkaline phosphatase at 12 months was achieved by 25.0% of patients treated with seladelpar compared to 0% on placebo.

In patients having moderate-to-severe itch at baseline, the seladelpar treated group improved their pruritus at 6 months compared to those in the placebo group.

Safety and tolerability were comparable between placebo and seladelpar groups and consistent with previous studies.

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