Boehringer signals intent in obesity

Biopharma boasts a crowded and competitive obesity pipeline, but Boehringer Ingelheim has seen enough to join the throng, and push its GLP-1/glucagon dual agonist into pivotal trials. The company confirmed as much today at its annual results press conference, with chief executive Hubertus von Baumbach telling journalists the project will move into phase 3 “as fast as possible”.

Hopes were raised around pivotal development earlier this month when Boehringer’s partner Zealand Pharma said phase 3 plans were being discussed. With mid-stage trials also completed in type 2 diabetes and Nash, this could mean a huge push for Boehringer – and a nice pay day for Zealand, which is eligible for up to €345m ($374m) in milestones and double digit royalties. 

The project, BI 456906, derives from a decade-old collaboration between Boehringer and Zealand Pharma. Not much data has been released so far outside of type 2 diabetes. In those patients BI 456906 promoted 9% mean body weight loss at 16 weeks at the highest dose, results at Obesity Week last year revealed. This is in line with high-dose Mounjaro monotherapy in the phase 3 Surpass 1 diabetes trial, a setting in which Lilly has already won approval.

In obesity Mounjaro is also the one to beat, for now at least. The GIP/GLP-1 agonist impressed last year in its first phase 3 obesity readout, Surmount 1. The remainder of the programme is due to read out in the coming months.  

When BI 456906 might move into phase 3 is not immediately clear; Evaluate Vantage is awaiting clarification from Boehringer. Phase 2 obesity data should be presented later this year, according to Zealand, with the ADA meeting in June a likely venue.

Von Baumbach described the project as “promising” and “holding significance” for Boehringer in the metabolic space. Several big beasts of the sector, including Lilly, Pfizer and Amgen, are already moving ahead with substantial programmes with novel agents in obesity, type 2 diabetes and Nash, so BI 456906 must be looking impressive.

As for BI 456906’s mechanism, it is not the only GLP-1/glucagon agonist in development, although signs from the class have not all been encouraging. Astrazeneca has taken cotadutide into phase 2, though it seems to be focusing on Nash, while Altimmune’s pemvidutide disappointed in a closely-watched mid-stage obesity trial only last week.

Nordea analysts have hope that BI 456906 will be different to pemvidutide, and promote greater weight loss. Boehringer's project has greater bias towards the GLP-1 receptor, which it hits at an 8:1 ratio, compared to a 1:1 ratio between GLP-1 and glucagon receptors for the Altimmune project, they wrote last week.