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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

 
• By Joseph Haas

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.

adaptive design - text in vintage letterpress wood type against grunge metal surface
Akero's Phase IIb/III adaptive trial is a first in NASH

Competition is heating up in the FGF21 analog class for non-alcoholic steatohepatitis, with Akero Therapeutics, Inc. preparing to initiate an adaptive Phase IIb/III study of its drug efruxifermin (EFX/AKR-001), which it says could provide a relatively quick path to producing pivotal data and give it a boost as the NASH space resettles after this year’s clinical development setbacks for Intercept Pharmaceuticals, Inc. and Genfit SA.

Leadership in the NASH space generally is seen as wide open again after Genfit’s Phase III failure in May with PPAR agonist elafibranor and Intercept’s complete response letter from the US Food and Drug Administration for FXR agonist obeticholic acid (OCA) on 29 June. (Also see "RESOLVE-IT Failure Dashes Genfit's NASH Hopes" - Scrip, 12 May, 2020

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