Boehringer Initiates phase III trials in MASH for survodutide

Boehringer Ingelheim, a biopharmaceutical firm involved in human and animal health, revealed that the FDA has given Breakthrough Therapy status to survodutide (BI 456906), a dual glucagon/GLP-1 receptor agonist for treating adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate or advanced fibrosis (stages 2 or 3). The Breakthrough Therapy designation advances the process of developing and examining drugs for life-threatening diseases that have shown early clinical signs of significant improvement compared to existing treatments.

Boehringer disclosed the start of two phase III clinical studies for survodutide for treating adults with MASH and fibrosis (scarring). LIVERAGE will investigate if survodutide can enhance MASH and/or fibrosis after 52 weeks of treatment and lower the chances of end-stage liver disease outcomes after around seven years of treatment in adults with MASH and moderate or advanced liver fibrosis (stages 2 or 3).

LIVERAGE-Cirrhosis will investigate if survodutide can decrease the likelihood of developing end-stage liver disease after around four and a half years of treatment in adults with NASH and compensated cirrhosis, which is characterized by severe liver scarring.

“Given the significant burden of MASH and the limited therapeutic options, novel approaches are urgently needed,” said Dr. Arun Sanyal, M.D., Professor of Medicine at Virginia Commonwealth University School of Medicine and Director of VCU’s Stravitz-Sanyal Institute for Liver Disease and Metabolic Health. “The phase III LIVERAGE studies represent an exciting opportunity to investigate whether survodutide, with its dual glucagon and GLP-1 receptor agonist mechanism of action, can help address this significant medical need."