Survodutide Phase 2 Trial Achieves Major Liver Disease Improvements in 83% of Adults with MASH

Zealand Pharma has announced that a Phase 2 clinical trial of survodutide, a treatment for metabolic dysfunction-associated steatohepatitis (MASH), has shown promising results. The trial, conducted by Boehringer Ingelheim, indicated that 83% of adults treated with survodutide experienced significant improvements in their liver condition, compared to 18.2% in the placebo group. The results were based on a 48-week treatment period and were statistically significant, with a response difference of 64.8% and a p-value of less than 0.0001.

Survodutide is a novel medication that acts as a dual agonist for the glucagon and GLP-1 receptors, which are crucial for metabolic regulation. It has previously demonstrated effectiveness in treating obesity and has now shown potential benefits for patients with MASH across various health aspects, including cardiovascular, renal, and metabolic health.

The Phase 2 trial was a double-blind, placebo-controlled study that evaluated three different doses of survodutide: 2.4 mg, 4.8 mg, and 6.0 mg. The trial's primary endpoint was met with survodutide showing a biopsy-proven improvement in MASH without an increase in fibrosis stages F1, F2, and F3. Additionally, all secondary endpoints were met, including a significant improvement in liver fibrosis.

David Kendall, MD, Chief Medical Officer of Zealand Pharma, expressed excitement over the trial's positive results and anticipation for the full data presentation, which is expected in the coming months. He also noted Boehringer Ingelheim's intention to expedite further development of survodutide for MASH, as they continue with the recruitment for an ongoing Phase 3 clinical trial program focused on obesity.

Survodutide was co-developed by Boehringer Ingelheim and Zealand Pharma, with Boehringer funding all related activities and being solely responsible for its clinical development. The medication has received U.S. FDA Fast Track Designation for the treatment of MASH and fibrosis and is also under evaluation in five Phase 3 trials as part of the SYNCHRONIZE program for individuals with overweight and obesity issues.

Zealand Pharma is a Danish biotechnology company that specializes in the development of peptide-based drugs. It has a history of advancing drug candidates into clinical development, with several reaching the market and others in late-stage development. The company maintains partnerships with various pharmaceutical firms and has a presence in both Denmark and the United States.