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CymaBay Shelves NASH Drug Seladelpar On Liver Safety Concerns

 
• By Joseph Haas

Atypical histological findings from a Phase IIb NASH study lead CymaBay to terminate mid-stage studies in NASH and PSC and place a Phase III PBC trial on hold.

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Histology readings showed unexpected safety signals in CymaBay's Phase IIb NASH trial

CymaBay Therapeutics Inc. already had revised the development strategy for its PPAR delta agonist seladelpar in non-alcoholic steatohepatitis (NASH) following disappointing liver fat-reduction readings from a Phase IIb study this past June, to shift to a liver enzyme endpoint. But the biotech is now shelving the drug for both NASH and primary sclerosing cholangitis (PSC), while placing on hold Phase III work with the compound in primary biliary cholangitis (PBC), based on abnormal biopsy findings.

The Newark, CA-based company said on 25 November that it made those decisions after assessments from a first tranche of liver biopsies in its Phase IIb NASH study revealed “atypical histological findings, including histology characterized as an interface hepatitis presentation, with or without biliary injury

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