Boehringer fast-tracks survodutide for late-stage MASH development amid positive data

Boehringer Ingelheim is set to advance the development of survodutide, a glucagon/GLP-1 receptor dual agonist, into Phase III trials for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). This decision follows the presentation of additional mid-stage data at the European Association for the Study of the Liver (EASL) congress. Carinne Brouillon, head of human pharma at Boehringer Ingelheim, highlighted the significance of these results, describing survodutide as potentially the best-in-class treatment for individuals suffering from MASH.

Boehringer Ingelheim, in collaboration with Zealand Pharma, reported in February that their Phase II study met its primary endpoint. The study demonstrated that up to 83% of adults with MASH who were administered the experimental drug experienced significant histological improvements without any worsening of fibrosis when compared to those given a placebo.

The trial also achieved several key secondary objectives, including notable improvements in liver fibrosis, although specific data were not disclosed at that time. Now, the results presented at the EASL and published in The New England Journal of Medicine (NEJM) provide more detailed insights. These results indicate that up to 52.3% of adults with fibrosis stages F1, F2, and F3 showed improvements in their fibrosis condition due to MASH. A sub-analysis further revealed that up to 64.5% of adults with fibrosis stages F2 and F3 achieved fibrosis improvement without any worsening of MASH.

Principal investigator Arun Sanyal commended the findings, suggesting that survodutide could emerge as a leading glucagon/GLP-1 receptor dual agonist, potentially transforming the treatment landscape for individuals with MASH and significant fibrosis.

In summary, the promising data from the Phase II study of survodutide have paved the way for its advancement into Phase III trials. If successful, this treatment could offer a new hope for patients struggling with MASH, particularly those with advanced stages of fibrosis.