Boehringer preps phase 3 for dual-action obesity drug
Armed with results from a phase 2 trial, Boehringer Ingelheim has said it will take its obesity drug candidate survodutide into a phase 3 programme later this year.
The glucagon/GLP-1 receptor dual agonist – partnered with Zealand Pharma and also known as BI 456906 – achieved up to 19% weight loss in people living with overweight or obesity in a study presented at the American Diabetes Association (ADA) congress in June.
The two companies are in hot pursuit of Novo Nordisk and Eli Lilly, currently pioneering a new wave of obesity therapies which some market watchers predict could make tens of billions of dollars per year within the next decade.
Like Novo Nordisk's already-approved GLP-1 agonist Wegovy (semaglutide) and Lilly's dual GIP/GLP-1 agonist Mounjaro (tirzepatide) – which is approved for diabetes and set for an FDA decision in obesity later this year – survodutide is given as a once-weekly subcutaneous injection.
The weight loss seen with survodutide seems to be at least as good and possibly a little better than its rivals, and according to Boehringer and Zealand could become the first obesity therapy that can not only reduce weight but also curb appetite.
There was one red flag in the phase 2 data, as around a quarter of patients taking the highest dose of survodutide discontinued treatment, mainly due to gastrointestinal side effects, compared to 4% of the placebo group.
The discontinuations mainly occurred during a dose-escalation phase and could be addressed with a gentler ramp-up in phase 3, according to Boehringer.
The designs of the three planned phase 3 trials are yet to be finalised, but the drugmaker has previously said it may look at raising the dose over a four-week period, rather than two weeks, to try to improve survodutide's tolerability.
The World Obesity Federation predicts that by 2025, 2.7 billion adults could be living with overweight or obesity, placing a high burden on individuals, healthcare systems, and society as a whole.
Survodutide is one of a string of new therapies emerging from the industry pipeline for obesity, setting up what looks likely to be fierce competition in the next few years.
Novo Nordisk is testing a Wegovy follow-up called CagriSema, based on semaglutide and amylin analogue cagrilintide, in phase 3, while Lilly has a triple agonist targeting GLP-1, GIP and glucagon known as retatrutide that is also being pushed forward quickly into pivotal trials. Meanwhile, Novo Nordisk, Lilly and Pfizer are working on daily oral GLP-1 agonists for patients who don't want to take injections.
Survodutide is also in development as a treatment for non-alcoholic steatohepatitis (NASH), another massive potential market that currently has no FDA-approved therapies.