Zealand Pharma A/S announced that Boehringer Ingelheim has reported breakthrough results from a survodutide Phase 2 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]. 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.

Today’s news follows data announced earlier this year when the trial met its primary endpoint.  These results demonstrated that up to 83.0% of adults achieved a statistically significant improvement of MASH versus placebo (18.2%), reinforcing the potential of survodutide as a best-in-class treatment.

“We are very excited by the impressive Phase 2 trial results announced today by Boehringer Ingelheim for survodutide in MASH”, said David Kendall, MD, Chief Medical Officer of Zealand Pharma. “These Phase 2 data provide evidence of clear differentiation that positions survodutide as a potential incretin-based treatment for both obesity and MASH. We are delighted that survodutide will advance into Phase 3 for the potential treatment of MASH.”

In this trial, survodutide demonstrated safety data consistent with GLP-1 based molecules, with no new safety data concerns.