Boehringer Ingelheim Discovered Novel Survodutide for the Treatment of Advanced Fibrosis
Boehringer Ingelheim has identified a novel treatment known as survodutide (BI 456906), a dual glucagon/GLP-1 receptor agonist, for adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced fibrosis (stages 2 or 3).
Survodutide functions as a dual agonist for both glucagon and GLP-1 receptors, which are involved in regulating metabolic processes. Currently, the drug is undergoing a thorough Phase III clinical development programme, which encompasses the LIVERAGE studies targeting individuals with MASH and fibrosis, as well as the SYNCHRONIZE studies aimed at those with overweight or obesity.
MASH is a chronic, progressive liver disease caused by excessive fat accumulation in the liver and is a more severe variant of metabolic dysfunction-associated steatotic liver disease (MASLD). In the United States, cases of MASH are expected to rise significantly, with projections indicating a 63% increase from 16.5 million cases in 2015 to 27 million cases by 2030.
This condition is often linked to cardiovascular, renal, and metabolic disorders, and it is estimated that 34% of individuals with obesity also suffer from MASH.
The LIVERAGE study aims to evaluate whether survodutide can improve MASH and/or fibrosis after 52 weeks of treatment and reduce the risk of progression to end-stage liver disease over approximately seven years in adults with MASH and moderate to advanced liver fibrosis (stages 2 or 3).
Additionally, LIVERAGE-Cirrhosis will investigate whether survodutide can lower the risk of end-stage liver disease over roughly four and a half years in patients with MASH and compensated cirrhosis (fibrosis stage 4), characterised by significant liver scarring.
The U.S. FDA has granted breakthrough therapy designation for survodutide as a treatment for adults with non-cirrhotic MASH and moderate to advanced fibrosis.
