Boehringer Ingelheim (BI), the German pharmaceutical colossus, has declared that it has been granted Breakthrough Therapy Designation (BTD) by China’s Center for Drug Evaluation (CDE) for its experimental drug candidate, survodutide (BI 456906). This designation underscores the drug’s promising therapeutic potential for patients suffering from metabolic dysfunction-associated steatohepatitis (MASH).
Derived from the natural intestinal hormone oxygen regulatory protein, survodutide is capable of simultaneously activating GLP-1 and glucagon receptors, thereby modulating metabolic functions. The glucagon receptor agonist component of survodutide is designed to boost energy expenditure and target the liver directly, aiding in the amelioration of liver fibrosis. Concurrently, the GLP-1 receptor agonist aspect of the molecule can significantly curb appetite while enhancing satiety. Phase II clinical trials have demonstrated that, in comparison to the placebo, adult MASH patients administered survodutide achieved markedly superior histological and fibrotic improvements, with an 83% improvement rate observed versus 18.2% in the placebo group.- Flcube.com