Novo to seek MASH approval for obesity drug with new results

Novo Nordisk announced on Friday that it will seek regulatory approval for semaglutide, the main component in its popular weight loss medication, for treating a common liver disease after favorable Phase 3 trial results. The company's press release revealed that semaglutide achieved its primary objectives in the initial part of a late-stage, placebo-controlled study on individuals with metabolic dysfunction-associated steatohepatitis (MASH).

The study, conducted over 72 weeks, demonstrated that 37% of participants taking semaglutide in conjunction with standard therapy showed improved liver scarring without their condition worsening. This was in comparison to 22.5% who received a placebo alongside standard care. Moreover, 63% of those on semaglutide experienced a resolution of MASH without their liver scarring deteriorating, compared to 34% of those on placebo.

Novo Nordisk reported that semaglutide was safe and had a well-tolerated profile, consistent with previous tests. However, the company did not disclose further details about the study, such as the drug's performance on secondary measures or the number of participants who might have discontinued treatment due to side effects. Comprehensive results are expected to be presented at a medical conference in 2024. The trial will continue for several years to evaluate semaglutide's effectiveness in preventing cirrhosis, a common complication of MASH.

The positive trial results suggest that semaglutide could become the first drug of its kind available for MASH, which affects millions of people and is a leading cause of liver transplants. Novo Nordisk plans to seek approval for semaglutide in the U.S. and Europe during the first half of 2025.

Martin Holst Lange, Novo's head of development, expressed satisfaction with the ESSENCE clinical trial outcomes, noting semaglutide's potential to assist individuals living with MASH. He highlighted that one in three people with overweight or obesity suffers from MASH, significantly impacting their health and representing a substantial unmet need.

MASH is caused by a toxic buildup of fat in the liver and often occurs alongside other metabolic diseases like diabetes. It has been a challenging target for drugmakers, with several promising treatments failing in trials over the years. The first medication to reach U.S. regulators, a drug from Intercept Pharmaceuticals, was rejected in 2023. However, a new generation of medicines has emerged. In March, Madrigal Pharmaceuticals' Rezdiffra became the first approved drug for MASH, experiencing a faster-than-expected launch. Other drugs from Akero Therapeutics and 89bio have also shown potential, though study results have been mixed.

GLP-1 drugs like semaglutide have become a promising treatment option. These drugs act on gut hormones and have shown significant effects on weight loss, heart health, and other conditions. MASH has been identified as a new opportunity for these drugs. Eli Lilly, Boehringer Ingelheim, and Zealand Pharma have reported encouraging findings in Phase 2 trials, leading investors to speculate that GLP-1 drugs could disrupt the market for other MASH therapies.

Despite the promising results, some Wall Street analysts remain skeptical. Several analysts commented on Friday that the findings do not distinguish semaglutide from other MASH drugs, leaving room for competition. The results suggest that GLP-1 drugs could address some aspects of MASH but are not a comprehensive solution or cure.

Shares of Madrigal Pharmaceuticals rose nearly 15% on Friday morning, with 89bio and Akero also experiencing gains in early trading.