Akero Therapeutics announces publication of Harmony Phase 2b trial results

Akero Therapeutics announced publication in The Lancet Gastroenterology & Hepatology of results from the HARMONY Phase 2b trial in nonalcoholic steatohepatitis, NASH. The paper, available online, provides data on the safety, tolerability, and efficacy of once-weekly subcutaneous injections of efruxifermin compared to placebo in patients with pre-cirrhotic NASH, fibrosis stage 2 or 3. Results showed that both EFX doses achieved statistical significance on primary and secondary histopathology endpoints after 24 weeks. Treatment with EFX was generally well-tolerated, with a tolerability profile comparable to that observed in Akero’s Phase 2a BALANCED study. Study participants in HARMONY exhibited characteristics associated with high risk of progressive NASH, presenting with obesity, type 2 diabetes, and stage 2 or 3 fibrosis. In this context, both doses of EFX demonstrated statistically significant and broadly-based effects on multiple secondary endpoints, including improvements in non-invasive markers of liver injury and fibrosis, liver fat content, glycemic control, lipoproteins, and body weight.