Pfizer has announced that it will be advancing a once-daily formulation of its oral glucagon-like peptide-1 (GLP-1) receptor agonist, danuglipron.
The drugmaker said it plans to conduct dose optimisation studies of the candidate in the second half of 2024, following “encouraging” data from an ongoing pharmacokinetic study.
Danuglipron is intended to keep blood sugar at healthy levels by increasing the amount of insulin released.
Additional potential effects of the investigational medicine include slowing down food digestion and increasing the feeling of fullness after eating, which may be associated with weight loss.
The open-label study has been evaluating the pharmacokinetics and safety of immediate and modified-release formulations of danuglipron in healthy adults aged 18 years and older.
The results have demonstrated a pharmacokinetic profile “supportive of once-daily dosing” and a safety profile consistent with prior studies of the drug, according to Pfizer.
Mikael Dolsten, chief scientific officer and president, Pfizer Research and Development, outlined that danuglipron has already demonstrated “good efficacy” in its twice-daily formulation and the company believes a once-daily formulation “has the potential to have a competitive profile in the oral GLP-1 space”.
“Following a thorough analysis of our previous phase 2b data and trial design, 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,” he said.
Pfizer said in December 2023 that it would not be advancing the twice-daily version of danuglipron into late-stage studies. The company had reported statistically significant reductions from baseline in body weight for all doses of the formulation, but noted “high discontinuation rates” of more than 50% across all doses in the phase 2b trial compared to approximately 40% with placebo.
The latest announcement came just days after researchers from Case Western Reserve University School of Medicine in the US found that type 2 diabetes patients being treated with GLP-1 receptor agonists were less likely to develop ten types of 13 obesity-related cancers.