Biomea Fusion has dosed the first participant in the Phase I trial of BMF-650, an investigational therapy, being developed to treat obesity.
Administered orally, BMF-650 is a small-molecule glucagon-like peptide-1(GLP-1) receptor agonist (RA).
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The Phase I study aims to evaluate BMF-650’s initial efficacy, tolerability and safety in otherwise healthy individuals who are overweight or obese.
Data on weight loss over a 28-day period at the highest dosage is anticipated to be available in the first half of 2026.
In preclinical studies, the once-daily administration of BMF-650 at doses of 10mg/kg and 30mg/kg in obese cynomolgus monkeys resulted in dose-dependent reductions in food intake and progressive weight loss over 28 days.
Biomea Fusion Research executive vice-president and BMF-650 programme lead Thorsten Kirschberg said: “Dosing the first patient represents a major milestone for the BMF-650 programme and the dedicated team behind it.
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By GlobalData“We are very pleased to advance BMF-650 into clinical evaluation, building on the compelling preclinical results in primates that demonstrated robust appetite suppression, weight loss, and glucose-lowering benefits.
“With its enhanced pharmacokinetic profile, including improved oral bioavailability and consistent plasma exposure, we believe BMF-650 has the potential to deliver distinct metabolic benefits in a convenient, once-daily oral form.”
BMF-650 is structurally related to orforglipron chemotype class and combines durable receptor activation and improved oral bioavailability for delivering strong metabolic benefits.
In June 2024, the US Food and Drug Administration (FDA) placed a full clinical hold on Biomea Fusion’s ongoing Phase I/II clinical trials assessing BMF-219 for type 1 and type 2 diabetes.
