Cholestatic liver disease, disorders related to slowing or stalling of the biliary system, have been fallback options for companies also working in the non-alcoholic steatohepatitis space, and two companies that struck out in NASH are on the verge of submitting their PPAR agonists for US approval in primary biliary cholangitis, where they would take on another failed NASH drug, Intercept Pharmaceuticals, Inc./Alfasigma SpA’s Ocaliva, in second-line treatment.
Key Takeaways
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CymaBay and Ipsen/Genfit both reported successful Phase III data for treatment of PBC at the 2023 AASLD meeting.
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Both drugs are PPAR agonists and are expected to replace FXR agonist Ocaliva as second-line therapies for primary biliary cholangitis
Data were presented at the American Association for the Study of Liver Disease annual meeting for both CymaBay Therapeutics, Inc.’s PPAR delta agonist seladelpar and Ipsen SAGenfit SA’s PPAR alpha/delta agonist elafibranor showing therapeutic benefit in PBC, but CymaBay’s drug also showed statistical significance on reducing pruritus, a key side effect seen with Ocaliva (obeticholic acid, an FXR agonist). (Also see "Genfit/Ipsen’s PBC Data Leave Door Open For CymaBay" - Scrip, 30 June, 2023
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