Pfizer Inc.’s stock PFE fell 4% premarket Friday, after the company said it’s not planning to push ahead to a Phase 3 trial of a twice-daily formulation of its oral GLP-1 candidate in adults with obesity and type 2 diabetes after high rates of adverse events in the Phase 2b trial. The company said that study met its primary endpoint of statistically significant change in body weight compared with placebo. Twice daily dosages of danuglipron demonstrated placebo-adjusted weight reductions ranging from 8% to 13% at 32 weeks and of 5% to 9.5% at 26 weeks. “While the most common adverse events were mild and gastrointestinal in nature consistent with the mechanism, high rates were observed (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 said in a statement. Pfizer is not planning to move the twice-daily formulation to Phase 3 studies, but said it believes a once-daily formulation could play a role in obesity treatment. “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,” said Dr. Mikael Dolsten, chief scientific officer and president of Pfizer R&D. Pfizer’s stock has fallen 40.5% in the year to date, while the S&P 500 SPX has gained 19%.
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