CymaBay Alters NASH Hypothesis After Phase IIb Failure In Hepatic Fat Reduction
Firm points to liver biomarker findings, saying they may yield clear liver benefit at 52 weeks. Both CymaBay's and Genfit's stock prices fell as investors wondered about broader read-through for the PPAR agonist class.
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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.
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.
NGM’s injectable might be best-suited as induction therapy for sicker NASH patients, Inventiva hopes its pan-PPAR agonist will outperform Genfit’s elafibranor, and Albireo thinks IBAT inhibition offers promise in NASH.