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Genfit/Ipsen’s PBC Data Leave Door Open For CymaBay

 
• By Joseph Haas

Genfit/Ipsen’s elafibranor and CymaBay’s seladelpar are vying to supplant Intercept’s Ocaliva in second-line primary biliary cholangitis, but elafibranor failed to hit a key differentiation endpoint in pruritus.

Liver care
Competition to Intercept in second-line PBC is looming • Source: Shutterstock

Genfit SA’s failed non-alcoholic steatohepatitis drug, the dual PPAR alpha/delta agonist elafibranor, met its primary endpoint and a key secondary endpoint in a Phase III study in primary biliary cholangitis (PBC) on 30 June, but by failing to demonstrate statistical significance versus placebo on another secondary endpoint measuring pruritus improvement, an opportunity remains for CymaBay Therapeutics, Inc. to demonstrate a best-in-class profile for its PBC candidate seladelpar, also a failed NASH candidate.

Both companies are looking to unseat Intercept Pharmaceuticals, Inc. in second-line PBC treatment, where that company’s Ocaliva (obeticholic acid) is the only drug approved to treat PBC patients who...

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