Danuglipron: Pfizer moves forward with once-daily weight-loss pill

Pfizer has selected a preferred once-daily modified-release formulation for its weight loss candidate danuglipron, as the company looks to get ahead in the oral weight loss market.

The company reached the preferred choice after an analysis of its ongoing Phase II pharmacokinetic study. Whilst several candidates showed encouraging data, one showed “the most favourable profile”, according to the company.

The company plans to conduct dose optimisation studies in the second half of 2024 where it will test multiple doses of its preferred modified-release formulation.

Taken as a tablet, Danuglipron is a glucagon-like peptide 1 (GLP-1) receptor agonist. Like other GLP-1 agonists, it works by increasing insulin release and suppressing glucagon release. These drugs can help patients lose weight by slowing down the digestion of food and increasing the feeling of fullness after eating.

Pfizer redirected resources to danuglipron after terminating its other GLP-1 programme for lotiglipron in June 2023. The decision to scrap the latter was due to elevated levels of transaminases, a type of liver enzyme.

Pfizer is confident in its once-daily dosing regimen, highlighting that results to date have demonstrated a pharmacokinetic profile supporting this. The company added that the drug’s safety profile in the ongoing study was consistent with earlier danuglipron studies, with no elevated levels of liver enzymes.

Pfizer research and development chief scientific officer Mikael Dolsten said: “We believe that with the preferred modified release formulation and future trial design optimisation, we can advance a competitive oral GLP-1 molecule into registration enabling studies, with the goal of addressing the present and persistent medical needs of people living with obesity.”

The weight loss market in pharma is in the midst of a boom. Novo Nordisk currently dominates the space with its GLP-1 agonist drug Wegovy (semaglutide) which reeled in sales of around $4.5bn in 2023, helping the company achieve its highest profit in decades.

Eli Lilly is a key player in the space with Mounjaro (tirzepatide). A study published in JAMA Internal Medicine study published earlier this week caused ripples in the investor sector, after it found that Eli Lilly’s active ingredient led to greater weight loss than Novo Nordisk’s semaglutide. Eli Lilly’s stock rose as a result while Novo Nordisk’s dropped. A weight loss pill, however, would provide even greater market opportunity over injections, providing efficacy data holds up.

“Pfizer moves forward with once-daily weight loss pill” was originally created and published by Clinical Trials Arena, a GlobalData owned brand.

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