Akero Therapeutics announced new analyses from its 96-week Phase 2b HARMONY trial of efruxifermin (EFX) for pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH). The analyses, presented at the European Association for the Study of the Liver (EASL) Congress 2025, used AI-based digital pathology to confirm EFX’s anti-fibrotic activity and demonstrated alignment with non-invasive tests. The data strengthen the evidence supporting EFX’s potential as a treatment for this serious metabolic disease.
These findings are important because they offer a more robust method for assessing drug efficacy in MASH trials. Traditional biopsy analysis, coupled with categorical pathology scoring, can introduce variability. The AI-based qFibrosis® platform, a continuous scoring scale, reduces this “noise” and provides a clearer picture of treatment effects, enabling researchers to better differentiate real improvements from placebo effects. This enhanced precision can expedite drug development and offer patients more effective treatments sooner.
The analyses showed strong concordance between qFibrosis® results and two non-invasive tests (ELF test and FibroScan®) in patients treated with 50mg of EFX. More than half of these patients were classified as responders by all three measures, compared to less than 5% of placebo patients. A post-hoc analysis also revealed that qFibrosis® detected treatment responses earlier than conventional pathology. At 24 weeks, qFibrosis® identified 18 responders in the 50mg EFX group, while conventional pathology identified only 10. However, at 96 weeks, the results from both methods were similar, indicating that qFibrosis® may offer an earlier indication of treatment efficacy.
This research reinforces the potential of EFX as a promising therapy for pre-cirrhotic MASH and highlights the value of AI-driven digital pathology in clinical trials. The ability to identify responders earlier using qFibrosis® could lead to more efficient trials and accelerate the development of much-needed treatments for MASH. This technology could also potentially inform personalized treatment strategies and ultimately improve outcomes for patients with this challenging condition.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
