Pfizer (NYSE:) shares rose higher in premarket trading Thursday following an announcement that the company is advancing the development of its once-daily weight-loss pill Danuglipron.
The drugmaker plans to carry out dose optimization studies in the second half of 2024 on various doses of their preferred modified release formulation to guide the registration-enabling studies.
The company’s shares were up nearly 4% in the premarket, at the time of writing.
“Obesity is a key therapeutic area for Pfizer, and the company has a robust pipeline of three clinical and several pre-clinical candidates,” said Mikael Dolsten, Chief Scientific Officer & President at Pfizer Research and Development.
“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,” he added.
“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 optimization, 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.”
Pfizer said the current open-label, randomized study is assessing the pharmacokinetics and safety of immediate- and modified-release formulations of danuglipron in healthy adults.
Results so far indicate a pharmacokinetic profile suitable for once-daily dosing and a safety profile consistent with previous studies, showing no liver enzyme elevations in over 1,400 participants.
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