Boehringer’s Ingelheim’s Survodutide Shows Liver Fibrosis Improvement

Zealand Pharma has disclosed that Boehringer Ingelheim has published findings from a sub-analysis of a Phase 2 trial using survodutide, showing that after 48 weeks of therapy, nearly 65% of adults at fibrosis stages F2 and F3 (mild to severe scarring) saw a decrease in fibrosis without their metabolic dysfunction-associated steatohepatitis (MASH) getting worse, compared to 25.9% for those with a placebo. Patients in the F2 and F3 cohorts are more likely to experience liver-related problems

The complete data findings were concurrently published in The New England Journal of Medicine and discussed at the European Association for the Study of the Liver Congress (EASL) 2024. After 48 weeks of therapy, the second endpoint reveals that, compared to 25.8% of individuals receiving placebo, over 52% of people administered survodutide saw an important reduction in liver scarring (fibrosis) stages F1, F2, and F3.

The data released comes after the study’s primary endpoint was reached previously this year. According to these findings, 83% of individuals saw a statistically significant improvement in MASH compared to 18.2% of those who received a placebo, indicating that survodutide has the potential to be the most effective treatment available.

Avid Kendall, the CMO of Zeland Pharma, remarked, “We are very excited by the impressive Phase 2 trial results announced today by Boehringer Ingelheim for survodutide in MASH.”

He indicated that the Phase 2 data demonstrate a distinct differentiation, positioning survodutide as a potential incretin-based therapy for both obesity and MASH. He also expressed pleasure that survodutide is moving forward into Phase 3 for the possible treatment of MASH.

Survodutide showed safety results in this trial that were in line with compounds based on GLP-1; no additional safety issues were identified.

Survodutide operates as a dual agonist of the glucagon and GLP-1 receptors, both of which are essential for regulating metabolic processes. Boehringer Ingelheim has a license to use survodutide from Zealand Pharma; Boehringer is alone in charge of the drug’s worldwide development and marketing. Zealand is entitled to co-promotion in the Nordic region.

For the management of MASH and fibrosis, survodutide was given Fast Track Designation by the U.S. FDA in May 2021. In November 2023, it was approved for use in the EMA PRIME program. Additionally, five Phase 3 trials, including individuals with obesity and overweight—both linked to MASH—are evaluating the effects of survodutide.

Zealand Pharma, founded in 1998, is a biotechnology firm that specializes in finding and creating medications based on peptides. Its headquarters is located in Copenhagen, Denmark and it operates actively in the U.S. More than 10 of Zealand’s inventions for drugs have progressed to the clinical stage; of these, two are now on the market and three are in the late stages of development.

The post Boehringer’s Ingelheim’s Survodutide Shows Liver Fibrosis Improvement appeared first on LifeSci Voice.