Boehringer shows its hand in obesity

Boehringer Ingelheim and partner Zealand Pharma have reported new clinical data in obesity for their dual glucagon/GLP1 agonist BI 456906, setting up a possible challenge to emerging therapies like Novo Nordisk’s Wegovy and Eli Lilly’s Mounjaro.

The drug is also in development as a treatment for non-alcoholic steatohepatitis (NASH), another massive potential market, and Boehringer believes its double mechanism of action could allow it to straddle both indications.

In the just-reported phase 2 trial, BI 456906 achieved up to 14.9% weight loss after 46 weeks in adults living with obesity or overweight without type 2 diabetes at the planned maintenance dose given as a weekly injection, meeting its primary endpoint.

That level of weight loss puts it in the same ballpark as phase 2 results with GLP-1 agonist Wegovy (semaglutide) – already approved for obesity – as well as Lilly’s dual GIP/GLP-1 agonist Mounjaro (tirzepatide), which is heading for an FDA decision for weight loss in October.

BI 456906 – which is now heading for phase 3 testing – is just one of the projects Boehringer is pursuing in obesity, seeking a slice of what is predicted to become a ten billion dollar market in the coming years.

Novo Nordisk has struggled to keep up with massive demand for Wegovy, and earlier this month, said it was restricting new patient starts on the drug to make sure those already on the drug would not have their treatment interrupted.

Mounjaro, meanwhile, is so far only approved for diabetes but is growing fast and recently generated phase 3 results suggesting it may be more effective than Wegovy at reducing weight – although it’s important to note that data did not come from a head-to-head trial.

Boehringer was also working with Zealand on a long-acting amylin analogue BI 473494 under the terms of their long-running collaboration, which has since been discontinued, and has an early-stage alliance with Gubra on novel peptide-based therapies.

“Obesity is one of many cardio-renal-metabolic diseases, which together represent one of the fastest growing health challenges worldwide,” said Boehringer’s head of human pharma, Carinne Brouillon.

“The distinct mode of action of BI 456906 targets multiple pathways pivotal to metabolic regulation, including those associated with obesity and liver disease,” she added.

A phase 2 study of BI 456906 in NASH is due to generate results before the end of the year, which, if positive, could open the way to another big opportunity for the drug.

At the moment, there are no FDA-approved therapies for the condition, although drugs from Intercept Pharma and Madrigal Pharma are in the pre-registration phase, with an FDA decision on the former expected next month.