Biomea Fusion Begins Phase I Study With First Patient Dosed For BMF-650, Its Innovative Oral GLP-1 Receptor Agonist

Biomea Fusion, Inc., a clinical-stage biopharmaceutical company focused on developing innovative treatments for diabetes and obesity, announced that the first patient has been dosed in its Phase I clinical trial evaluating BMF-650, an investigational next-generation oral small molecule glucagon-like peptide-1 (GLP-1) receptor agonist.

BMF-650 is being developed as an oral therapy for obesity and is part of a new class of small molecule GLP-1 receptor agonists. Structurally related to the orforglipron chemotype, BMF-650 has been specifically engineered to enhance oral bioavailability, reduce pharmacokinetic variability, and maintain strong plasma protein binding with potent intrinsic activity. These characteristics are intended to deliver consistent therapeutic effects and improved patient convenience through a once-daily oral regimen.

In preclinical studies involving obese cynomolgus monkeys, once-daily oral administration of BMF-650 at doses of 10 mg/kg and 30 mg/kg led to clear, dose-dependent reductions in daily food intake and continuous weight loss over a 28-day treatment period. Animals treated with 10 mg/kg and 30 mg/kg achieved average body weight reductions of approximately 12% and 15%, respectively, from baseline. The treatment was well tolerated and demonstrated a favorable safety profile. These outcomes compared positively with published preclinical data from other leading oral GLP-1 receptor agonists currently in development, underscoring BMF-650’s strong potential in weight management.

Thorsten Kirschberg, Ph.D., Executive Vice President of Research at Biomea Fusion and program lead for BMF-650, commented, “Dosing the first patient marks a significant milestone for the BMF-650 program and reflects the hard work of our dedicated team. We are excited to move into the clinical phase following the promising preclinical results that showed meaningful appetite suppression, weight reduction, and glucose-lowering benefits. With its optimized pharmacokinetic profile, improved oral absorption, and consistent plasma exposure, we believe BMF-650 could provide unique metabolic advantages in a simple, once-daily oral format. We look forward to presenting the first clinical data in the first half of 2026.”

The ongoing Phase I clinical trial is designed to evaluate the safety, tolerability, and preliminary efficacy of BMF-650 in otherwise healthy overweight or obese adults. The study will also explore early indicators of weight reduction, with 28-day weight loss data from participants receiving the highest dose expected to be reported in the first half of 2026.