Akero Looks To Accelerate Path To Pivotal NASH Data With Phase IIb/III Protocol
89Bio Builds Case For Safety Advantage As FGF Competition Heats Up
Akero gets FDA’s ok to conduct Phase IIb/III study of FGF21 analog efruxifermin in biopsy-confirmed non-alcoholic steatohepatitis patients. With NASH leadership up in the air, Akero, 89bio and other FGF analog sponsors jockey for top spot.
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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.
Looking ahead to lengthy, expensive Phase III NASH studies, Akero looks to tap public markets for $200m. Analysts call EFX’s Phase IIb data potentially best-in-class.
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.