FDA considers noninvasive liver biomarker to accelerate MASH drug trials

The FDA is weighing a noninvasive method, liver stiffness via transient elastography, as a surrogate endpoint in MASH drug trials, potentially accelerating development of new therapies. The liver stiffness biomarker is linked to outcomes like mortality and liver events.

Why it matters: This shift could reduce reliance on liver biopsies, streamlining clinical trials and improving recruitment for therapies targeting metabolic dysfunction-associated steatohepatitis (MASH), a serious form of fatty liver disease.

Backstory: MASH, formerly known as NASH, often requires multiple biopsies for diagnosis and monitoring, an invasive, error-prone process that hinders trial efficiency. The FDA accepted a letter of intent to qualify a safer ultrasound-based biomarker. The letter was sent by Echosens, a manufacturer of ultrasound-powered liver scanners, with the support of pharma giants Eli Lilly, Boehringer Ingelheim, and Novo Nordisk.

Big picture: The move marks a broader trend toward noninvasive tools in drug development. It reflects rising momentum in metabolic disease research and opens the door for faster, more accessible treatments.

Zoom in: Stock prices jumped for MASH-focused biotechs like Madrigal, Viking, Inventiva, and Altimmune following the news from the FDA.