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Pfizer advances once-daily weight loss pills as it catches up to the lucrative market

Pfizer advances once-daily weight loss pills as it catches up to the lucrative market

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 danugliprone, an oral glucagon-like peptide-1 (GLP-1) receptor agonist.

Pfizer plans to conduct dose optimization studies in the second half of 2024 and evaluate multiple doses of the preferred modified-release formulation to inform registration that enables studies.

Read also: What happens to Pfizer on Thursday? Pharma Giant’s Shares Tick Lower.

“Obesity is an important therapeutic area for Pfizer, and the company has a robust pipeline of three clinical and several preclinical candidates. The most advanced of these, danugliprone, has shown good efficacy in a twice-daily formulation, and we believe that a formulation a once daily 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 evaluates the pharmacokinetics and safety of immediate- and modified-release formulations of danugliprone administered orally to healthy adults 18 years of age or older.

Study results have shown a pharmacokinetic profile that supports once-daily dosing and a safety profile consistent with previous danugliprone studies, including no liver enzyme elevations observed in more than 1,400 study participants.

In December 2023, Pfizer reported top-line data from the phase 2b study of twice-daily danuglipron in adults with obesity and without type 2 diabetes.

The company said the study met its primary endpoint, showing a statistically significant change in body weight from baseline, but danugliprone was linked to “high rates” of mild gastrointestinal side effects, affecting more than half of patients in all dose groups drops out of the trial.

Pfizer said future development of danuglipron will be focused on a once-daily formulation and end evaluation formulation twice daily.

Price Action: At last check on Thursday, PFE shares were up 1.78% at $28.88.

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