Pfizer won’t advance twice-daily danuglipron into Phase 3 studies

Pfizer announced topline data from the Phase 2b clinical trial investigating its oral Glucagon-like peptide-1 receptor agonist, or GLP-1RA, candidate, danuglipron, in adults with obesity and without type 2 diabetes. The study met its primary endpoint demonstrating statistically significant change in body weight from baseline. While the most common adverse events were mild and gastrointestinal in nature consistent with the mechanism, high rates were observed, including up to 73% nausea; up to 47% vomiting; up to 25% diarrhea. High discontinuation rates, greater than 50%, were seen across all doses compared to approximately 40% with placebo, the company stated. Ongoing pharmacokinetic study of once-daily formulation of danuglipron will continue, the outcome of which will inform a path forward and at this time, twice-daily danuglipron formulation will not advance into Phase 3 studies, Pfizer said. “We believe an improved once-daily formulation of danuglipron could play an important role in the obesity treatment paradigm, and we will focus our efforts on gathering the data to understand its potential profile,” said Mikael Dolsten, MD., PhD., Chief Scientific Officer & President, Pfizer Research and Development. “Results from ongoing and future studies of the once-daily danuglipron modified release formulation will inform a potential path forward with an aim to improve the tolerability profile and optimize both study design and execution.” Future development of danuglipron will be focused on a once-daily formulation, with pharmacokinetic data anticipated in the first half of 2024, the company added. In pre-market trading, Pfizer shares are down $1.06, or over 3%, to $29.41.