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On Thursday, Pfizer Inc. (NYSE:PFE) announced that, based on results from the ongoing Phase 1 pharmacokinetic study, it has selected its preferred once-daily modified release formulation for danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist.
Pfizer plans to conduct dose optimization studies in the second half of 2024, evaluating multiple doses of the preferred modified release formulation to inform the registration enabling studies.
Also Read: What’s Going On With Pfizer On Thursday? Pharma Giant’s Shares Tick Lower.
“Obesity is a key therapeutic area for Pfizer, and the company has a robust pipeline of three clinical and several pre-clinical candidates. The most advanced of them, danuglipron, has demonstrated good efficacy in a twice-daily formulation, and we believe a once-daily formulation has the potential to have a competitive profile in the oral GLP-1 space,” said Mikael Dolsten, Chief Scientific Officer & President, Pfizer R&D.
The 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.
Study results have demonstrated a pharmacokinetic profile supportive of once-daily dosing and a safety profile consistent with prior danuglipron studies, including no liver enzyme elevations observed in more than 1,400 study participants.
In December 2023, Pfizer reported topline data from the Phase 2b trial of twice daily danuglipron in adults with obesity and without type 2 diabetes.
The company said the study met its primary endpoint, demonstrating a statistically significant change in body weight from baseline, but danuglipron was tied to “high rates” of mild gastrointestinal side effects, leading to more than half of the patients across all dose groups dropping out from the trial.
Pfizer said the future development of danuglipron will be focused on a once-daily formulation and stop evaluating twice-daily formulation.
Price Action: At last check Thursday, PFE shares were up 1.78% at $28.88.
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Posted In: PFE
