Boehringer Ingelheim and Zealand Pharma’s dual glucagon/GLP-1 receptor agonist elicited significant topline Phase II results in metabolic dysfunction-associated steatohepatitis.
Pictured: Boehringer Ingelheim’s office in Silicon Valley/iStock, Sundry Photography
Boehringer Ingelheim on Monday revealed new Phase II data for its investigational glucagon/GLP-1 receptor dual agonist survodutide, showing that it could elicit significant improvements in patients with metabolic dysfunction-associated steatohepatitis.
Specific data from the announcement were sparse but the pharma revealed that at 48 weeks, 83% of patients treated with survodutide saw significant biopsy-proven improvement in metabolic dysfunction-associated steatohepatitis (MASH) without the worsening of their fibrosis stages, the study’s primary endpoint. By comparison, only 18.2% of placebo counterparts achieved this outcome.
The response difference was 64.8% in favor of survodutide, an effect that was statistically significant, with a p-value less than 0.0001, according to Boehringer Ingelheim.
Survodutide also aced its secondary endpoints including reduced liver fibrosis and lower liver fat content, as measured by a specific magnetic resonance imaging technique.
The pharma will present complete results and analyses from the mid-stage trial in the coming months.
Carinne Brouillon, head of human pharma at Boehringer Ingelheim, in a statement said that these data position survodutide as a potential “best-in-class treatment, and we believe its true differentiator is the action of the glucagon receptor agonism which works directly on the liver.”
Boehringer Ingelheim “will move forward as quickly as possible in MASH,” Brouillon said, adding that the company will continue survodutide’s development in other indications including obesity.
Developed in collaboration with Zealand Pharma, survodutide is an investigational dual agonist of both the GLP-1 and glucagon receptors, both of which play central roles in the regulation of metabolic functions. According to Zealand’s website, activating these two key gut hormone receptors simultaneously could lead to greater efficacy than the current single-hormone agonists.
Under their license and collaboration deal, Boehringer Ingelheim is funding all R&D activities related to survodutide and will also take charge of its commercialization. Zealand is eligible to certain milestones on top of high-single to low-double digit royalties on potential global sales.
Beyond MASH, the partners are also studying survodutide in people with obesity and who are overweight, for which it is running five Phase III trials including SYNCHRONIZE-1, SYNCHRONIZE-2 and SYNCHRONIZE-CVOT. Boehringer Ingelheim launched these three studies in May 2023, seeking to assess survodutide in different sub-populations of overweight or obese people, including those with diabetes, cardiovascular diseases and chronic kidney disease.
In June 2023, Boehringer Ingelheim and Zealand released Phase II data for survodutide demonstrating that the dual agonist could reduce body weight by around 20%. Of note, at the time, weight loss had not yet plateaued at 46 weeks indicating that longer treatment duration could lead to better efficacy.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
