NASH Updates: Intercept Moves Toward Re-Filing, Madrigal De-Risks Phase III
AASLD Briefing: While working on new biopsy reviews to address CRL, Intercept also might consider filing for approval in cirrhotic patients if REVERSE study succeeds. Plus other updates on NASH programs.
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89bio’s pegozafermin met co-primary endpoints of fibrosis reduction and NASH resolution in Phase IIb; the company said its methodology yielded lower placebo responses than in Akero’s Phase IIb study.
While neither company reported new data from their ongoing trials at AASLD, the firm’s competing THRβ agonists are viewed as leading lights in the non-alcoholic steatohepatitis competition.
With Akero’s FGF21 analog showing ability to reduce fibrosis and resolve non-alcoholic steatohepatitis, some analysts think classmate BIO89-100 could yield a better overall profile. NASH data are starting to pour in.