Boehringer Ingelheim 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. F2 and F3 patient populations are at increased risk of developing liver-related complications.

The secondary endpoint shows that up to 52.3% of adults treated with survodutide (BI 456906) achieved a significant improvement in liver scarring (fibrosis) stages F1, F2 and F3, versus 25.8% with placebo after 48 weeks of treatment.

This follows data announced earlier this year when the trial met its primary endpoint. These results demonstrated that up to 83% of adults achieved a statistically significant improvement of MASH versus placebo (18%), reinforcing the potential of survodutide as a best-in-class treatment.

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.

In this Phase II trial, survodutide also demonstrated significance versus placebo for all other secondary endpoints after 48 weeks of treatment. Actual treatment results showed that up to 87% of adults achieved at least a 30% relative reduction in liver fat versus 19.7% with placebo, as well as a relative reduction in liver fat content of up to 64.3% versus 7.3% with placebo.

Survodutide is licensed to Boehringer Ingelheim from Zealand Pharma, with Boehringer solely responsible for development and commercialization globally. Zealand has a co-promotion right in the Nordic countries.

Survodutide was granted U.S. FDA Fast Track Designation in 2021 and the European Medicines Agency (EMA) granted access to the Priority Medicine (PRIME) Scheme for MASH with fibrosis in November last year.

Survodutide is also being explored in five Phase III studies in people who are overweight and obesity, both of which are associated with MASH.