Akero’s Phase II Success Could Augur Brighter Days For NASH R&D

Akero Therapeutics, Inc.’s successful Phase IIb data with efruxifermin (EFX) in pre-cirrhotic non-alcoholic steatohepatitis (NASH) patients provided good news for the company, but also more generally for the NASH space, which has been mostly dominated by trial failures and regulatory setbacks during the past two years. In addition, EFX’s ability to reduce fibrosis and resolve NASH in the Phase IIb HARMONY trial also was considered reason for optimism for Akero’s direct competitor, 89bio, Inc.

Both companies have FGF21 analogs – EFX and pegozafermin (BIO89-100) – in Phase II for NASH, with a central thesis that this mechanism can both reduce liver fat content and suppress fibrosis. (Also see "Akero Looks To Accelerate Path To Pivotal NASH Data With Phase IIb/III Protocol" - Scrip, 24 September, 2020.) A key consideration for any FGF21 analog is extending the protein’s half-life to enable weekly injectable therapy, since most NASH development candidates are daily oral therapies. The class has attracted significant attention, including from several deeper-pocketed companies such as Bristol Myers Squibb Company, Merck & Co., Inc