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

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 are intolerant to or have inadequate therapeutic response with the first-line therapy, ursodeoxycholic acid (UDCA)