Akero Therapeutics Phase IIb trial of NASH candidate efruxifermin fails to impress

US clinical-stage biotech Akero Therapeutics (Nasdaq: AKRO) saw its shares slump 59% to $48.44, after it released new data Phase IIb data on its lead product candidate efruxifermin (EFX) in patients with compensated cirrhosis (F4) due to non-alcoholic steatohepatitis (NASH), joining a string of companies failing in their attempts in this therapy area.

Having shown efficacy in earlier-stage patients, Akero was looking to its Phase IIb SYMMETRY clinical trial to show EFX reduces fibrosis in people with compensated cirrhosis. However, the study failed as, overall, the fibrosis benefit was not statistically significant at 36 weeks.

Putting a positive spin on the results, Akero noted that a trend was observed for the primary endpoint of fibrosis improvement at 36 weeks, with 22% and 24% of the 28mg and 50mg EFX-treated groups, respectively, experiencing at least a one-stage improvement in liver fibrosis and no worsening of NASH, compared with 14% for placebo.