Akero Therapeutics and HistoIndex Present New Analyses of Phase 2b HARMONY Trial in Oral and Poster Presentations at the EASL Congress 2025

Core Insights - Akero Therapeutics announced results from the 96-week Phase 2b HARMONY trial of efruxifermin (EFX) for patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) [1][6] - The study demonstrated the antifibrotic activity of EFX, with over half of patients treated with 50mg EFX classified as responders by AI-based digital pathology and non-invasive tests, compared to fewer than 5% of placebo patients [2][3] Group 1: Study Details - The HARMONY study was a multicenter, randomized, double-blind, placebo-controlled trial involving 128 biopsy-confirmed adult MASH patients with fibrosis stage 2 or 3 [6] - Patients received either 28 mg or 50 mg EFX or placebo for 24 weeks, with the study continuing for up to 96 weeks [6] - The primary efficacy endpoint was the proportion of subjects experiencing ≥1-stage fibrosis improvement without worsening of MASH [6] Group 2: Results and Analysis - AI-based qFibrosis® analysis showed that after 24 weeks, the antifibrotic effect of EFX was greater than conventional pathology, with 18 patients identified as responders compared to 10 by conventional methods [3] - At Week 96, consistency was observed between conventional pathology and qFibrosis®, with 77% and 81% of patients classified as responders, respectively [3] Group 3: Presentations and Speakers - An oral presentation titled "Alignment of response assessed by non-invasive fibrosis biomarkers and HistoIndex AI-based qFibrosis histology in metabolic dysfunction associated steatohepatitis (MASH) clinical trials" was given by Prof. Quentin M. Anstee [4] - A poster presentation titled "qFibrosis enables earlier detection of fibrosis response in Efruxifermin-treated patients with F2-F3 MASH in 96-week HARMONY study" was presented by Dr. Jörn M. Schattenberg [5] Group 4: About EFX - Efruxifermin (EFX) is Akero's lead product candidate for MASH, currently evaluated in three ongoing Phase 3 studies [7][8] - EFX has shown potential to reverse fibrosis, resolve MASH, and improve insulin sensitivity and lipoprotein profiles, addressing the complex disease state of MASH [7]