Novo Nordisk's semaglutide has shown promising results in treating metabolic dysfunction-associated steatohepatitis (MASH), leading to a surge in the stock prices of companies developing MASH therapies. The announcement stems from the headline results of part 1 of the ongoing ESSENCE trial, a pivotal phase 3, double-blinded trial involving 1,200 adults with MASH and moderate to advanced liver fibrosis.
The ESSENCE trial evaluated the effect of once-weekly semaglutide 2.4 mg on liver tissue compared to placebo on top of standard of care for the first 800 randomized people at 72 weeks. The trial achieved its primary endpoints by demonstrating a statistically significant and superior improvement in liver fibrosis with no worsening of steatohepatitis, as well as resolution of steatohepatitis with no worsening of liver fibrosis with semaglutide 2.4 mg compared to placebo.
Clinical Significance
The results of the ESSENCE trial highlight the potential of semaglutide in addressing the significant unmet need in MASH treatment. According to Martin Holst Lange, executive vice president and head of Development at Novo Nordisk, "Among people with overweight or obesity, one in three live with MASH. This has a serious impact on their health and represents a significant unmet need."
Market Impact
Following the announcement, Madrigal Pharmaceuticals (MDGL), which recently received approval for its drug Rezdiffra, experienced a substantial increase in its stock price, rising by $57.73, or 22%, to $317.07. Other companies in the MASH space, such as 89Bio (ETNB) and Akero Therapeutics (AKRO), also saw their shares rise by 16% and 1%, respectively.
The positive results from the ESSENCE trial suggest that semaglutide could become a valuable treatment option for patients with MASH, a condition affecting a significant portion of the overweight and obese population.
