Drugs

Twice-Daily Weight Loss Drug Stalls: Pfizer

Pfizer says it will not advance its twice-daily weight-loss drug danuglipron into Phase 3 studies due to high discontinuation rates in a just-reported Phase 2b clinical trial. Instead, the company plans to advance a once-daily formulation of the oral Glucagon-like peptide-1 receptor agonist (GLP-1RA) candidate for treating obesity in those without Type 2 diabetes.

“Twice-daily dosing of danuglipron 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,” Pfizer says. “Placebo-adjusted reductions in mean body weight ranged from -8% to -13% at 32 weeks and -5% to -9.5% at 26 weeks.”

The company says that 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. No new safety signals were reported and treatment with danuglipron was not associated with increased incidence of liver enzyme elevation compared to placebo.”

Moving forward, Pfizer says it will focus on an “improved” once-daily drug formulation. “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.” Pharmacokinetic data on the once-daily formulation are expected in the first half of 2024.

Danuglipron was discovered and developed in-house at Pfizer. The GLP-1RA is intended to work by keeping blood sugar at healthy levels and by increasing the amount of insulin released and lowering the amount of glucagon released into the blood, Pfizer says. It also slows down the digestion of food and increases the feeling of fullness after eating.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome