Boehringer to present mid-stage MASH trial results after accidental release

Boehringer Ingelheim is set to unveil promising phase 2 trial results for survodutide, a treatment for metabolic dysfunction-associated steatohepatitis (MASH), at the European Association for the Study of Liver Congress. The abstract detailing these findings was accidentally made public but has since been retracted.

Zealand Pharma, which licenses survodutide to Boehringer, revealed in a press release that the abstract had been "unintentionally and temporarily made available through the congress website." Despite this mishap, the topline data from the double-blind trial had already been released earlier this year. These findings showed that 83% of adults treated with survodutide experienced significant improvements in liver disease associated with MASH, including noticeable reductions in liver fibrosis, a form of scarring.

The newly detailed results in the abstract highlight a crucial secondary endpoint: improvements in liver fibrosis without a concurrent worsening of MASH symptoms. Zealand Pharma confirmed that these results demonstrate "highly statistically significant reductions in fibrosis" when using survodutide.

Survodutide, developed jointly by Boehringer Ingelheim and Zealand Pharma, is a dual agonist of the glucagon and GLP-1 receptors. This novel mechanism of action is designed to activate both receptor pathways. Currently, survodutide is being assessed in five phase 3 trials aimed at individuals with overweight and obesity. Boehringer and Zealand believe that survodutide has the potential to be a leading treatment option for MASH/NASH.

MASH/NASH, a severe form of nonalcoholic fatty liver disease, is a significant contributor to liver-related deaths and affects around 1.5 million people in the United States alone. In March, Madrigal Pharmaceuticals received the first FDA approval for a MASH treatment with their once-daily, oral THR-β agonist, Rezdiffra.

The positive phase 2 results for survodutide add to the growing body of evidence supporting the drug's efficacy in treating liver conditions linked to metabolic disorders. With ongoing phase 3 trials, Boehringer Ingelheim and Zealand Pharma are optimistic about the future of survodutide as a best-in-class treatment for those suffering from MASH/NASH.