Data presented at the virtual American Diabetes Association meeting has Pfizer excited about the promise of its GLP-1R Agonist PF-06882961.
Data presented at the virtual American Diabetes Association meeting has Pfizer excited about the promise of its GLP-1R Agonist PF-06882961.
During a Monday presentation at the conference, Pfizer showcased Phase I data from a study assessing PF-06882961, an oral small molecule glucagon-like peptide-1 receptor (GLP-1R) agonist in type 2 diabetes patients that showed significant promise in the reduction of glucose levels and body weight. In the Phase I study, which assessed the safety tolerability, pharmacokinetics and pharmacodynamics of the drug, 98 patients with type 2 diabetes who had been taking metformin, were randomized to receive either placebo or PF‑06882961.Data from the presentation showed patients who received the oral small molecule saw improvements in fasting plasma glucose (FPG), 24-hour mean daily glucose (MDG) and body weight. Improvements were seen at all dose levels, but the highest results were achieved by patients who received 120 mg doses of the drug. Those patients saw an average reduction in body weight of about 18 pounds, as well as 89.7 mg FPG reductions and 105.9 mg reductions in MDG. Pfizer plans to hold a call with analysts on June 18 to provide in-depth details of the Phase I data.
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Type 2 diabetes impacts more than 28 million people in the U.S. alone. Despite the available treatment options, many adults with type 2 diabetes have poorly managed blood sugar that can increase the risk of developing serious diabetes-related complications. GLP-1 agonist drugs are popular treatment options for diabetes patients. The class of drug has seen multiple regulatory approvals, including Ozempic, Victoza, Trulicity and more. GLP-1 agonists help diabetes patients lower blood glucose levels, including hemoglobin A1C, and aid in weight loss.
Most GLP-1 drugs are injectable medications. An oral drug like Pfizer’s PF-06882961 will likely be a welcome change for diabetes patients. Last year Novo Nordisk won approval for Rybelsus, the first oral GLP-1 receptor agonist for type 2 diabetes. Earlier this year, Novo Nordisk’s Ozempic, an injectable GLP-1 AR, won new approval to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or death in adults with type 2 diabetes and known heart disease.
Additionally, Pfizer said multiple, oral doses of PF-06882961 were safe and well-tolerated in adult participants with type 2 diabetes. The majority of adverse events were mild and included nausea, dyspepsia, diarrhea, headache and constipation. There were no deaths and no serious adverse events related to dosing of PF‑06882961, Pfizer said.
