CymaBay’s Stalled Seladelpar Back In Play For PBC

 
• By Joseph Haas
  
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Weeks after lifting of an FDA clinical hold, CymaBay says it will resume development of its PPAR agonist in primary biliary cholangitis. It will initiate a new Phase III trial but also use data from a terminated Phase III study.

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CymaBay is taking a second chance on seladelpar in PBC after FDA lifted a clinical hold

CymaBay Therapeutics, Inc. is back in business with its PPAR delta agonist seladelpar in primary biliary cholangitis, although the firm’s plans for studying the compound in non-alcoholic steatohepatitis are more nebulous. About two weeks after a clinical hold for seladelpar was lifted, CymaBay revealed on 3 August that the drug showed both efficacy and tolerability qualities in a modified intent-to-treat readout from the terminated Phase III ENHANCE study and will move into a new Phase III trial for PBC.

ENHANCE was designed to provide 12-month data on alkaline phosphatase (ALP) and bilirubin levels in PBC patients who either had...

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