Novo Nordisk axes once-monthly GLP-1/GIP agonist and MASH prospect

Novo Nordisk has axed its once-monthly dual GLP-1/GIP receptor agonist, ending (PDF) development of a drug candidate that it singled out as an exciting part of its pipeline earlier this year.

Marcus Schindler, Ph.D., chief scientific officer at Novo, had talked up the subcutaneous once-monthly prospect at a capital markets day in March. Discussing Novo’s early-stage diabetes pipeline at the time, Schindler focused on the drug candidate over five other molecules, explaining that “infrequent dosing, in particular in diabetes, but also obesity, are big topics for us.” The CSO added that the phase 1 prospect “could add significantly to convenience.” 

Analysts latched onto the potential importance of the once-monthly candidate, with multiple attendees asking Novo for additional information. Yet, this morning Novo revealed it had actually killed off the drug in the weeks after the investor event.

On an earnings call with analysts this morning, Novo’s EVP of Development Martin Holst Lange, M.D., Ph.D., stressed that the phase 1 study of the candidate had only ever been “exploratory.”

“While we definitely can use the data, the current profile was not something that we would take into further clinical development,” he explained.

However, the Big Pharma does see once-monthly delivery as convenient for patients and will continue to explore this either through the “next generation of this technology or alternative technologies,” Lange added.

 

The candidate was already part of a broader push by Novo to support infrequent dosing. Back at the investor event in March, Schindler had discussed the chemistries the company is using to prolong the effects of incretins, a class of hormones that includes GLP-1.

“We are obviously very interested ... in technologies that are suitable for a number of key molecules out there that, if we wish to do so, we can deploy this technology. And those technology investments for us will take precedence over just solving for a single problem,” Schindler said at the time.

Novo disclosed the termination of the once-monthly GLP-1/GIP program alongside the news that it has stopped a phase 1 trial of its VAP-1 inhibitor in metabolic dysfunction-associated steatohepatitis (MASH). The drugmaker again cited “portfolio considerations” as the reason for stopping the study and ending development of the candidate.

Novo licensed an inhibitor of SSAO and VAP-1 from UBE Industries for use in MASH in 2019. A phase 1 trial got underway in healthy volunteers in November. Novo lists one VAP-1 inhibitor in its clinical-phase pipeline.