89bio’s Phase IIb Data Heighten Competition Within NASH FGF21 Analog Class

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.

Two racers
Competition between 89bio and Akero in NASH is tightening • Source: Shutterstock

The street hailed 89bio, Inc.’s Phase IIb top-line data readout for pegozafermin (BIO89-100) in non-alcoholic steatohepatitis (NASH) on 22 March, saying it largely levels the playing field with Akero Therapeutics, Inc. and its FGF21 analog, which yielded successful Phase IIb data last September. One analyst called the 89bio dataset “unequivocally robust and definitive PoC results,” while another asserted that the two companies’ recent data position the FGF21 class as the best “high-efficacy mechanism” in NASH.

When Akero unveiled Phase IIb data on 16 September showing that a weekly dose of efruxifermin (EFX) could both reduce fibrosis and resolve NASH in pre-cirrhotic patients, it helped validate the FGF21 analog class and provided a boost generally for the setback-laden therapeutic space. (Also see "89bio Hopes Akero’s Success In Cirrhotic NASH Is Positive For FGF21 Class" - Scrip, 24 March, 2021

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