Zealand Pharma: Boehringer Ingelheim to Present Positive Phase 2 Survodutide Results in MASH at EASL

June 6, 2024 – Zealand Pharma announced today that Boehringer Ingelheim will present promising results from a Phase 2 trial of survodutide (BI 456906) targeting metabolic dysfunction-associated steatohepatitis (MASH) at the European Association for the Study of Liver Congress (EASL) 2024, scheduled for June 7. 

This announcement follows a previous release (Company announcement 8/2024) detailing the trial's success in achieving its primary endpoint. Specifically, the double-blind, placebo-controlled Phase 2 study tested three doses of survodutide—2.4 mg, 4.8 mg, and 6.0 mg—over 48 weeks, demonstrating significant histological improvement in MASH without exacerbating fibrosis.

The newly disclosed abstract includes a significant secondary endpoint: a ≥1 stage decrease in fibrosis without worsening MASH. The outcomes showed notable reductions in fibrosis stages F1, F2, and F3, indicating mild to advanced scarring improvements. Safety data for survodutide were consistent with those of other GLP-1 based treatments, with no new safety concerns identified.

Zealand Pharma had no prior knowledge of the abstract's availability before it was inadvertently posted on the congress website. The company will share additional updates as they become relevant.

About Survodutide (BI 456906)
Survodutide is a dual agonist for glucagon and GLP-1 receptors, playing a crucial role in managing metabolic functions. Boehringer Ingelheim holds the global development and commercialization rights, with Zealand Pharma retaining co-promotion rights in Nordic countries. The U.S. FDA awarded survodutide Fast Track Designation in May 2021 for treating MASH and fibrosis. The European Medicines Agency (EMA) also included survodutide in its Priority Medicine (PRIME) scheme for MASH with fibrosis in November 2023. Additionally, survodutide is undergoing five Phase 3 trials focusing on overweight and obesity, conditions closely associated with MASH. More information can be found on clinicaltrials.gov.

Zealand Pharma A/S Overview
Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology firm specializing in peptide-based medicines. The company has successfully advanced over ten drug candidates into clinical development, with two already on the market and three in late-stage trials. Zealand Pharma collaborates with various pharmaceutical companies for both developmental and commercial activities. Established in 1998, the company is headquartered in Copenhagen, Denmark, with operations in the United States.

This announcement was made to provide an official update on the status and findings of the Phase 2 trial. The company eagerly anticipates further developments and the upcoming presentation at EASL 2024. For further details on Zealand Pharma's business and initiatives, please visit their official website.

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