Akero Therapeutics Announces Publication of Phase 2b SYMMETRY Trial in the New England Journal of Medicine

Core Insights - The publication of the Phase 2b SYMMETRY trial results in the New England Journal of Medicine highlights the potential benefits of efruxifermin (EFX) in improving fibrosis in patients with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH) after 96 weeks of treatment [1][3][4] Company Overview - Akero Therapeutics is a clinical-stage company focused on developing treatments for serious metabolic diseases, including MASH, with its lead product candidate being efruxifermin (EFX) [5][10] - The company is currently conducting three ongoing Phase 3 clinical studies related to EFX, building on the results of previous Phase 2b trials [5][10] Study Details - The SYMMETRY trial was a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study involving 182 patients with biopsy-confirmed compensated cirrhosis (F4, Child-Pugh A) due to MASH [9] - The primary endpoint was defined as ≥1-stage fibrosis improvement without worsening of MASH at 36 weeks, with secondary outcomes assessed at 96 weeks [3][9] Efficacy Results - At 36 weeks, 19% of participants in the EFX 50mg group and 18% in the EFX 28mg group met the primary endpoint, compared to 13% for placebo [3] - At 96 weeks, 29% of participants in the EFX 50mg group and 21% in the EFX 28mg group showed fibrosis improvement without MASH worsening, compared to 11% in the placebo group [3] Safety and Tolerability - EFX was associated with improvements in noninvasive markers of liver injury and fibrosis, as well as markers of insulin sensitivity and lipid metabolism compared to placebo [4] - The safety profile of EFX was consistent with previous trials, with observed adverse events primarily being mild to moderate gastrointestinal issues [4] Disease Context - MASH is estimated to affect 17 million Americans and is characterized by excessive fat accumulation in the liver, leading to inflammation and fibrosis [6] - Approximately 20% of patients with MASH may progress to cirrhosis, which poses a higher risk of mortality [6][8]