Buoyed by encouraging pharmacokinetic data from an ongoing study, Pfizer (NYSE:PFE) has decided to proceed with the development of a once-daily formulation of its oral weight-loss drug, danuglipron.
Danuglipron (PF-06882961) is an investigational GLP-1 receptor agonist developed in-house at Pfizer. An ongoing open-label, randomized study is evaluating the pharmacokinetics and safety of immediate- and modified release formulations of danuglipron administered orally in healthy adults 18 years or older.
To date, study results have shown a pharmacokinetic profile supportive of once-daily dosing, with a safety profile consistent with prior danuglipron studies, including no liver enzyme elevations observed in more than 1,400 study participants.
The drugmaker plans to conduct dose optimization studies in the second half of 2024, with a focus on the preferred formulation to inform the registration enabling studies.
Pfizer (PFE) shares rose around 4% in early trading on Thursday
Last month, Pfizer’s (PFE) CEO Albert Bourla had said that the drugmaker is testing three new weight loss drugs, one of which will have a different mechanism from currently available GLP-1 agonists.
Bourla did not reveal the exact mechanism of the third drug, but mentioned the other two would be GLP-1 candidates, similar to Novo Nordisk’s (NVO) Wegovy.
Pfizer (PFE) is looking to capture a piece of the lucrative weight-loss drug market, with three clinical and several pre-clinical candidates in its pipeline.
However, the current weight loss blockbusters, Eli Lilly’s (LLY) Zepbound and Novo Nordisk’s (NVO) Wegovy, are likely to dominate the market even if other drugs are approved, according to analysts speaking during a panel discussion on GLP-1 drugs at the recent Seeking Alpha Investing Summit in New York.