Akero Therapeutics Announces Lancet Publication of the Phase 2b HARMONY Clinical Trial Demonstrating 96 Weeks Treatment with EFX Reduced Liver Fibrosis in Patients with Pre-cirrhotic MASH

Core Insights - The publication of the 96-week results from the Phase 2b HARMONY trial indicates the potential of efruxifermin (EFX) to significantly reduce the risk of fibrosis progression in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) [1][2][3] Company Overview - Akero Therapeutics, Inc. is a clinical-stage company focused on developing treatments for serious metabolic diseases, particularly MASH, which has a high unmet medical need [1][12] - Efruxifermin (EFX) is Akero's lead product candidate, currently being evaluated in three ongoing Phase 3 studies targeting different stages of MASH [9][12] Trial Results - The HARMONY trial was a 96-week multicenter, randomized, double-blind, placebo-controlled study involving 128 adult participants with biopsy-confirmed MASH and moderate to advanced fibrosis [2][11] - In the mITT population at week 96, 49% of participants receiving 50mg EFX achieved at least one stage of fibrosis improvement without worsening of MASH, compared to 19% for placebo (p=0.0030) [3][4] - Improvements in fibrosis were also noted in patients with more advanced disease, indicating EFX's potential effectiveness across different stages of MASH [3][4] Secondary Endpoints - The secondary endpoint of MASH resolution without fibrosis worsening was achieved by 40% of participants receiving 28mg EFX and 37% receiving 50mg EFX, compared to 19% for placebo [4] - A composite endpoint of both MASH resolution and at least one stage of fibrosis improvement was met by 35% and 28% of participants in the 50mg and 28mg EFX groups, respectively, versus 7% for placebo [4] Safety and Tolerability - EFX was generally well tolerated, with a safety profile consistent with previous trials; the most common adverse events were mild to moderate gastrointestinal issues [6] - A small reduction in bone mineral density was observed after 96 weeks of EFX treatment, although the clinical significance of this finding remains to be determined [6] Overall Impact - The sustained reductions in fibrosis and MASH observed in the trial reflect an overall improvement in whole-body metabolic health, including reduced dyslipidemia and increased insulin sensitivity [7] - The results from the HARMONY trial, along with data from the SYMMETRY trial, suggest that EFX has the potential to transform patient outcomes, particularly for those with a high fibrosis burden [3][7]