Novo Nordisk's semaglutide has shown positive results in the first phase of its Phase III ESSENCE trial, demonstrating significant improvements in liver fibrosis and resolution of Metabolic Associated Steatohepatitis (MASH). The double-blind study involved 1,200 adults with MASH and moderate to severe liver fibrosis, highlighting the potential of semaglutide as a treatment for this progressive liver condition.
The ESSENCE trial, spanning 240 weeks, divided participants in a 2:1 ratio, administering either 2.4mg of semaglutide or a placebo alongside standard treatment. By week 72, 37% of the semaglutide group showed improvement in liver fibrosis without worsening of fatty liver hepatitis, compared to 22.5% in the placebo group. Furthermore, 62.9% of patients in the semaglutide group experienced resolution of fatty liver hepatitis without fibrosis worsening, versus 34.1% in the placebo group.
Safety and Tolerability
Semaglutide displayed a strong safety profile and good tolerability throughout the trial. This is a crucial factor for a treatment targeting a chronic condition like MASH, where long-term adherence is essential for efficacy.
Regulatory Pathway
Martin Holst Lange, Executive Vice President of R&D at Novo Nordisk, expressed optimism about semaglutide's potential to aid MASH patients. The company is moving forward with plans to seek regulatory approval in the U.S. and EU by the first half of 2025, marking a significant step towards providing a new treatment option for MASH.
Market Context
While Novo Nordisk's stock showed minimal changes following the announcement, Madrigal Pharmaceuticals experienced a significant stock increase due to its drug Rezdiffra, the first FDA-approved medication for MASH. The American Liver Foundation estimates that approximately 5% of U.S. adults are affected by MASH, underscoring the substantial patient population and market potential. Eli Lilly also reported positive Phase II trial results for its drug tirzepatide in treating MASH earlier this year, indicating a growing interest and investment in this therapeutic area.
