Boehringer Ingelheim’s glucagon/GLP-1 receptor dual agonist survodutide has demonstrated efficacy for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease connected with other cardiovascular, renal, and metabolic conditions. 

The Phase II trial (NCT04771273) met its primary endpoint, wherein 83% of patients treated with survodutide saw significant biopsy-proven improvement in MASH without the worsening of their fibrosis stages, compared to 18.2% of patients who took the placebo.  

Boehringer Ingelheim’s candidate stands out from other GLP-1 receptor agonists in that it also targets the hormone glucagon. Simultaneously activating these two key gut hormone receptors could potentially produce more efficacious results than the current single-hormone agonists, such as Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound, the two main players for obesity.  

In the Phase II trial, secondary endpoints evaluating reduced liver fibrosis and lower liver fat content, as measured by a specific magnetic resonance imaging (MRI) techniques were also met. 

Boehringer, in partnership with the Danish biotech Zealand, is investigating survodutide in five clinical trials for obesity, including three—SYNCHRONIZE-1, SYNCHRONIZE-2 and SYNCHRONIZE-CVOT—which were kicked off in May 2023. 

The booming obesity market is forecast to reach $37.1bn in the seven major markets (US, France, Germany, Italy, Spain, UK and Japan) in 2031, according to a report on GlobalData’s Pharma Intelligence Center. 

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In June 2021, the US Food and Drug Administration (FDA) granted fast track designation for survodutide, with the European Medicines Agency (EMA) following suit, granting access to the Priority Medicine (PRIME) scheme for MASH with fibrosis in November 2023. The scheme enables earlier access to treatments that targets conditions with an unmet medical need. 

In the 26 February announcement accompanying the data, head of human pharma at Boehringer Carinne Brouillon said: “These MASH results show survodutide has potential to become a best-in-class treatment, and we believe its true differentiator is the action of the glucagon receptor agonism which works directly on the liver.” 

Earlier this year, Boehringer reinforced its interest in MASH entering into a multi-target collaboration with Suzhou Ribo Life Science and Ribocure Pharmaceuticals (Ribo) targeting the condition in a deal worth $2bn. This collaboration comes six years after Boehringer joined forces with Dicerna Pharmaceuticals to discover and develop new therapeutics using Dicerna’s GalXC technology platform, for the treatment of liver diseases including MASH.