Akero Therapeutics’ efruxifermin shows efficacy in Phase 2b MASH, fibrosis trial

Akero Therapeutics (AKRO) announced publication of 96-week final results from the Phase 2b HARMONY trial in The Lancet in adults with biopsy-confirmed metabolic dysfunction-associated steatohepatitis – MASH – and moderate or advanced fibrosis. Continued treatment with EFX from 24 to 96 weeks resulted in more participants exhibiting improvements in fibrosis and MASH, such that there was near complete reversal of disease in almost one-third of participants treated with the 50mg dose of EFX. In the modified intent-to-treat population at week 96, 49% of participants who received 50mg EFX achieved at least one stage fibrosis improvement without worsening of MASH evaluated by liver histology – the primary endpoint -, vs. 19% for placebo. The secondary endpoint of MASH resolution without fibrosis worsening was achieved by 40% of participants receiving 28mg EFX and 37% receiving 50mg EFX in the mITT population at week 96, vs. 19% for placebo. A composite endpoint of both MASH resolution and greater than or equal to1-stage fibrosis improvement was met by 35% and 28% of participants in the 50mg and 28mg EFX treatment groups, respectively, vs. 7% for placebo. EFX was generally well tolerated, with a safety profile consistent with previous trials. Confirmation of these potential benefits of EFX is being evaluated in the ongoing Phase 3 SYNCHRONY clinical trial program.