Akero Therapeutics and HistoIndex Present New Analyses of Phase 2b HARMONY Trial in Oral and Poster Presentations at the EASL Congress 2025
May 10, 2025 – Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical – Akero Therapeutics, EASL Congress 2025, HistoIndex, clinical trials, hepatology, histopathology, metabolic and infectious diseases, metabolic dysfunction-associated steatohepatitis
- 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.
10 May 2025 — California, US — Akero Therapeutics, Inc, 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®.
Details for the presentations are as follows:
Oral Presentation
Title: Alignment of response assessed by non-invasive fibrosis biomarkers and HistoIndex AI-based qFibrosis histology in metabolic dysfunction associated steatohepatitis (MASH) clinical trials: a new roadmap for robust drug efficacy assessment demonstrated in the HARMONY trial
Speaker: Prof. Quentin M. Anstee, Ph.D., FRCP, Ruth & Lionel Jacobson Chair of Personalised Medicine, Dean of Research & Innovation in the Faculty of Medical Sciences, Newcastle University, UK
Date/Time: Saturday, May 10, 2025, from 10:30 am – 10:45 am CET
Abstract Identifier: OS-096
Oral Session: MASLD: Clinical and therapeutical aspects II
Poster presentation
Title: qFibrosis enables earlier detection of fibrosis response in Efruxifermin-treated patients with F2-F3 MASH in 96-week HARMONY study
Speaker: Jörn M. Schattenberg, M.D., Professor of Medicine, Director of the Department of Medicine, Saarland University Medical Center, University of Saarland
Date/Time: Saturday, May 10, 2025, from 8:30 am – 4:00 pm CET
Abstract Identifier: TOP-458
Session: Poster – MASLD: Therapy
About Akero Therapeutics
Akero Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including metabolic dysfunction-associated steatohepatitis (MASH). Akero’s lead product candidate, efruxifermin (EFX), is currently being evaluated in three ongoing Phase 3 clinical studies: SYNCHRONY Histology in patients with pre-cirrhotic (F2-F3 fibrosis) MASH, SYNCHRONY Outcomes in patients with compensated cirrhosis (F4) due to MASH, and SYNCHRONY Real-World in patients with MASH or MASLD (metabolic dysfunction-associated steatotic liver disease). The Phase 3 SYNCHRONY program builds on the results of two Phase 2b clinical trials, the HARMONY study in patients with pre-cirrhotic MASH and the SYMMETRY study in patients with compensated cirrhosis due to MASH. Akero is headquartered in South San Francisco. Visit us at akerotx.com.
