Boehringer Ingelheim today announced breakthrough results from a survodutide Phase II trial sub-analysis that demonstrate up to 64.5% of adults with fibrosis stages F2 and F3 (moderate to advanced scarring) achieved an improvement in fibrosis without worsening of metabolic dysfunction-associated steatohepatitis (MASH), versus 25.9% with placebo after 48 weeks of treatment [response difference: 38.6% (95% CI 18.1% – 59.1%), p=0.0005].1 F2 and F3 patient populations are at increased risk of developing liver-related complications.
The full data results were presented today at the European Association for the Study of the Liver Congress (EASL) 2024 and published simultaneously in The New England Journal of Medicine.
Survodutide is a glucagon/GLP-1 receptor dual agonist with a novel mechanism of action, and the first to show this level of fibrosis benefit in a Phase II MASH trial after 48 weeks of treatment. The glucagon agonist component in survodutide has the potential to increase energy expenditure and has a direct impact in the liver, which could contribute to the improvement of fibrosis. The GLP-1 agonist component decreases appetite while increasing fullness and satiety.
“I am particularly excited about the findings of the Phase II trial in survodutide, which demonstrate the potential for glucagon agonism, in addition to GLP-1, to both improve MASH and shift the needle on fibrosis,” said Dr. Arun Sanyal, M.D., Professor of Medicine, Physiology and Molecular Pathology at Virginia Commonwealth University School of Medicine, and Principal Investigator of the trial. “These data position survodutide as a leading glucagon/GLP-1 receptor dual agonist that could be a game-changer for people living with MASH and clinically significant fibrosis.”
“Today’s breakthrough fibrosis results further reinforce survodutide’s potential as a best-in-class treatment for people living with MASH. We will advance quickly into Phase III trials,” said Carinne Brouillon, PharmD, Head of Human Pharma, Boehringer Ingelheim. “New treatments are urgently needed for MASH, a disease connected with cardiovascular, renal and metabolic conditions like obesity, and we are excited to continue these important discussions with healthcare authorities.”
