Benzinga - by Vandana Singh, Benzinga Editor.
Pfizer Inc (NYSE: PFE) reported topline data from the Phase 2b trial investigating its oral weight loss drug Glucagon-like peptide-1 receptor agonist (GLP-1RA) candidate, danuglipron (PF-06882961), in adults with obesity and without type 2 diabetes.
The company says the study met its primary endpoint, demonstrating a statistically significant change in body weight from baseline, but danuglipron was tied to “high rates” of mild gastrointestinal side effects, leading to more than half of the patients across all dose groups dropping out from the trial.
Twice-daily dosing of the drug showed statistically significant reductions from baseline in body weight for all doses, with mean reductions ranging from -6.9% to -11.7%, compared to +1.4% for placebo at 32 weeks and -4.8% to -9.4%, compared to +0.17% for placebo at 26 weeks.
Placebo-adjusted reductions in mean body weight ranged from -8% to -13% at 32 weeks and -5% to -9.5% at 26 weeks.
Pfizer reported that up to 73% of patients experienced nausea, up to 47% reported vomiting, and up to 25% had diarrhea.
Patients discontinued at rates greater than 50% across all doses compared to 40% of patients on placebo.
No new safety signals were reported, and treatment with danuglipron was not associated with increased incidences of liver enzyme elevation compared to placebo.
“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.
Future development of danuglipron will be focused on a once-daily formulation, with pharmacokinetic data anticipated in the first half of 2024.
Price Action: PFE shares are down 4.20% at $29.19 during the premarket session on the last check Friday.
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