Akero Therapeutics Reports Statistically Significant Histological Improvements at Week 96 in Phase 2b HARMONY Study

Core Insights - Akero Therapeutics released preliminary topline week 96 results from the Phase 2b HARMONY study, demonstrating significant efficacy of efruxifermin (EFX) in improving fibrosis in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) [1][2][16] - The study showed that 75% of patients in the 50mg EFX group and 46% in the 28mg EFX group achieved at least a one-stage improvement in fibrosis without worsening of MASH, compared to 24% in the placebo group [1][3] - EFX also demonstrated a 2-stage improvement in fibrosis for 36% of the 50mg group and 31% of the 28mg group, significantly higher than the placebo rate of 3% [2][3] Efficacy Results - The primary endpoint of the study was met, with the 50mg EFX group showing a 41% improvement at week 24, which increased to 75% at week 96 [1][3] - The placebo-adjusted effect size for fibrosis improvement without worsening of MASH increased from 21% to 52% for the 50mg EFX group between week 24 and week 96 [4][5] - Among patients with advanced F3 fibrosis, 68% of the 50mg EFX group experienced at least a one-stage improvement in fibrosis without worsening of MASH, compared to 14% for placebo [5][9] Safety and Tolerability - EFX was generally well-tolerated, with no deaths reported and serious adverse events balanced across dose groups [11][12] - The most common adverse events were mild gastrointestinal issues, which were transient [11][12] Future Outlook - Akero is optimistic about the ongoing Phase 3 SYNCHRONY studies, which will further evaluate EFX's efficacy in broader patient populations [6][18] - The company plans to report results from the SYMMETRY study, which focuses on patients with compensated cirrhosis, in the first quarter of 2025 [12][18]