EU approves AI tool to accelerate MASH drug development

NETHERLANDS – The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved an artificial intelligence (AI) tool designed to speed up the development of treatments for metabolic dysfunction-associated steatohepatitis (MASH).

This marks the first time an AI-powered system has been officially recognized for analyzing liver biopsy samples in MASH clinical trials.

Developed by PathAI, the AIM-NASH tool uses machine learning (ML) to assess disease severity with greater accuracy and consistency than traditional methods.

The system was trained using over 100,000 biopsy annotations from 59 pathologists across nine large clinical trials, analyzing more than 5,000 liver biopsies.

Improving accuracy and reducing variability

According to CHMP, the AI tool has demonstrated the ability to assess disease activity with significantly less variability than the current manual method, which relies on multiple pathologists reaching a consensus.

“The traditional approach to evaluating MASH biopsies is subjective and prone to variability,” CHMP noted. “The AIM-NASH tool aims to improve accuracy, repeatability, and reproducibility in clinical trials.”

The tool has the potential to streamline drug development, allowing researchers to enrol patients and evaluate treatment outcomes more efficiently, by standardizing biopsy assessments,

AI to assist, not replace, pathologists

Despite its approval, CHMP emphasized that the AI tool is meant to support—not replace—human expertise.

“The AIM-NASH tool is designed as a supplement to pathologist review and is not a substitute for expert evaluation,” the committee stated. “It is intended to be used alongside the assessment of a qualified liver pathologist.”

The AI system will assist a central pathologist in MASH clinical trials for patient selection and monitoring disease progression in Phase II and III studies.

A competitive landscape in MASH drug development

The approval of the AI tool comes at a time when pharmaceutical companies are in a race to develop effective MASH treatments.

In 2023, Madrigal Pharmaceuticals’ THR-β receptor agonist, Rezdiffra (resmetirom), became the first drug approved by the U.S. Food and Drug Administration (FDA) for MASH treatment.

The drug is currently under review in the EU, with a decision expected later this year and a planned launch in Germany in the second half of 2025.

However, competition is heating up, with GLP-1 receptor agonists—popular for diabetes and weight loss—showing promising results in MASH clinical trials.

Key contenders include Novo Nordisk’s semaglutide, Eli Lilly’s tirzepatide, and survodutide, co-developed by Boehringer Ingelheim and Zealand Pharma.