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

Analysis of EFX results with AI-based digital pathology underscores the potential value in evaluating histopathology response

Data contribute to growing body of support around the anti-fibrotic activity of EFX in patients with pre-cirrhotic MASH

SOUTH SAN FRANCISCO, Calif., May 10, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced results from new analyses of the 96-week Phase 2b HARMONY trial of efruxifermin (EFX) in patients with pre-cirrhotic (F2-F3 fibrosis) metabolic dysfunction-associated steatohepatitis (MASH) in an oral presentation and a poster presentation at the European Association for the Study of the Liver (EASL) Congress 2025 taking place May 7-10, in Amsterdam, the Netherlands.

The presentations corroborate the antifibrotic activity previously reported by conventional pathology for EFX in patients with pre-cirrhotic MASH. Specifically, among patients treated with EFX, digital pathology analysis by HistoIndex’s AI-based qFibrosis showed concordance at the individual level with two non-invasive tests (NIT) of liver fibrosis—ELF test score and liver stiffness measurement (FibroScan)—with more than half of patients treated with 50mg EFX classified as responders by all three endpoints compared to fewer than 5% of placebo patients.

“One of the challenges of developing a MASH investigational drug is distinguishing treatment effect from placebo ‘noise’ due to the inherent variability of biopsy sampling coupled with categorical pathology scoring,” said Kitty Yale, chief development officer at Akero. “As a continuous scoring scale, AI-based qFibrosis, combined with the two NITs, reduces placebo noise, allowing the potent anti-fibrotic effect of EFX to be clearly differentiated from placebo.”

The poster presentation, based on a post-hoc analysis of the 96-week HARMONY trial in patients with F2-F3 MASH quantifying the amount of collagen in each zone of the liver using qFibrosis, describes how the antifibrotic effect of EFX after 24 weeks treatment was greater than observed by conventional pathology, but after 96 weeks it was similar. For example, qFibrosis analysis of Week 96 biopsy samples from 50mg EFX patients (N=26) revealed consistency between conventional pathology and qFibrosis, with totals of 20 (77%) (conventional pathology) and 21 (81%) (qFibrosis), respectively. However, only 10 of these patients were identified as responders at Week 24 by conventional pathology, whereas 18 of them were detected as responders at Week 24 using qFibrosis.