Akero Therapeutics reports results from Phase 2B HARMONY study

Akero Therapeutics released preliminary topline week 96 results from HARMONY, a Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis, fibrosis stage 2 or 3. The study previously met its primary endpoint of greater than or equal to1 stage improvement in fibrosis with no worsening of MASH after 24 weeks of treatment for both the 50mg EFX (41%) and 28mg EFX (39%) dose groups, compared to 20% for the placebo arm. At week 96, the response rates on this endpoint increased to 75% for 50mg EFX and 46% for 28mg EFX, compared to 24% for placebo. The study also met additional histology endpoints at week 96-notably 36% and 31% of patients treated with 50mg EFX and 28mg EFX experienced a 2-stage improvement in fibrosis without worsening of MASH-which is more than 10-fold the placebo rate of 3%. Results for all of the histological endpoints are summarized in the table below, based on either the primary analysis or intent-to-treat analysis. “Notwithstanding inherent limitations in making cross-trial comparisons, the statistically significant results for greater than or equal to1- and 2-stage fibrosis improvement and no worsening of MASH observed for 50mg EFX at week 96 are the largest response rates reported publicly to date for these endpoints in any MASH population,” said Stephen Harrison, M.D., medical director of Pinnacle Clinical Research and the HARMONY study’s principal investigator. “I believe the magnitude and general consistency of results observed across the Phase 2a BALANCED and Phase 2b HARMONY studies in patients with pre-cirrhotic MASH are reasons to be optimistic about results of the ongoing Phase 3 SYNCHRONY Histology study and the potential for EFX to be an important MASH medicine, if approved.”