Boehringer’s Obesity Drug with Dual Mechanism Ready for Phase III

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Boehringer Ingelheim, Obesity, GLP-1 receptor, BI 456906, Eli Lilly, survodutide, Novo Nordisk

Boehringer Ingelheim is forging ahead with its obesity drug candidate, survodutide, moving it into a Phase III program following promising results from a Phase II trial. Developed in partnership with Zealand Pharma and also known as BI 456906, this glucagon/GLP-1 receptor dual agonist demonstrated remarkable potential, achieving up to 19% weight loss in individuals grappling with overweight or obesity. Presented at the American Diabetes Association (ADA) congress in June, these outcomes have emboldened the companies to progress to the next stage of clinical development.

In the race to address obesity, Boehringer Ingelheim and Zealand Pharma are hot on the heels of Novo Nordisk and Eli Lilly, frontrunners in the pursuit of novel obesity therapies. Industry experts foresee a potential for these medications to generate tens of billions of dollars annually within the coming decade.

Similar to Novo Nordisk’s approved GLP-1 agonist Wegovy (semaglutide) and Lilly’s dual GIP/GLP-1 agonist Mounjaro (tirzepatide), which is awaiting an FDA decision for obesity, survodutide follows suit by offering a once-weekly subcutaneous injection. Notably, the weight loss achieved with survodutide appears to be at least on par with its competitors and potentially even superior. Boehringer and Zealand assert that this therapy could pave the way to becoming the first obesity treatment capable of not only reducing weight but also curbing appetite.

“With a strong heritage in cardio-renal-metabolic disease, we are continuing to expand and accelerate our portfolio in this area with the aim of bringing survodutide to patients in need as quickly as possible. There is a significant unmet medical need for effective treatments for obesity. With its dual mode of action, survodutide has the potential to further improve outcomes for people living with the disease and its associated complications.” 

– Carinne Brouillon, Head of Human Pharma, Boehringer Ingelheim

However, the Phase II data did raise concerns as around 25% of patients receiving the highest dose of survodutide discontinued treatment, primarily due to gastrointestinal side effects, compared to only 4% in the placebo group. Boehringer suggests that this issue could be mitigated by implementing a gentler dose escalation phase during the Phase III trials.

The details of the upcoming Phase III trials are yet to be finalized, but Boehringer has indicated that it might consider a more gradual four-week dose increase instead of two weeks to enhance the drug’s tolerability.

The World Obesity Federation projects that by 2025, a staggering 2.7 billion adults might be grappling with being overweight or obese. This not only places a significant burden on individuals but also on healthcare systems and society as a whole.

Survodutide is just one among several promising therapies emerging in the pipeline to combat obesity. Novo Nordisk is exploring CagriSema, a follow-up to Wegovy, while Lilly is rapidly advancing its triple agonist, retatrutide, targeting GLP-1, GIP, and glucagon. Additionally, efforts are underway to develop daily oral GLP-1 agonists, catering to patients averse to injections.

Intriguingly, survodutide is also being evaluated as a potential treatment for non-alcoholic steatohepatitis (NASH), a significant market with a current lack of FDA-approved therapies. As the landscape of obesity treatment evolves, these developments usher in a period of intense competition and promise for patients and the healthcare industry alike.

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