89Bio’s NASH Hopes Hang On Demonstrating Best-In-Class FGF21 Profile
89Bio thinks its Phase II FGF21 analog could prove best-in-class in NASH due to a longer half-life than Bristol’s pegbelfermin, and avoid the LDL-increasing effects seen with NGM’s FGF19 analog.
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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.
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.
At EASL 2021, Akero presented efruxifermin data showing benefit in cirrhotic NASH patients and strong liver fat reduction, but may be challenged in the FGF21 analog class by 89Bio.