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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Analysts say the cirrhosis-reversing benefit seen with Akero’s efruxifermin portends well for the entire class, and that 89bio might differentiate on safety, tolerability and dosing frequency.
Follow-up Phase IIa data shows strong antifibrotic and NASH-resolution effects for Akero’s efruxifermin, an FGF21 analog. Analysts are calling the drug potentially best in class.
With approval timeline for OCA now thoroughly unclear and Genfit on the ropes, might the top spot in NASH end up with Galmed, AbbVie, Madrigal, Inventiva or Gilead instead?