On Monday, Oct. 27, 2025, Biomea Fusion announced that the first patient was dosed in its Phase I clinical trial of BMF‑650, an oral next‑generation GLP‑1 receptor agonist. The milestone marks the transition of BMF‑650 from preclinical studies to human testing and demonstrates the company’s ability to move its covalent chemistry platform into clinical development.
In preclinical studies, daily oral dosing of BMF‑650 at 10 mg/kg and 30 mg/kg produced dose‑dependent reductions in food intake and progressive weight loss of approximately 12 % and 15 % in obese cynomolgus monkeys over 28 days. The compound was well tolerated and showed a favorable safety profile, supporting its progression to a first‑in‑class oral GLP‑1 therapy.
The Phase I trial will enroll otherwise healthy overweight or obese participants and will evaluate safety, tolerability, and preliminary efficacy over 28 days, with weight‑loss data at the highest dose expected to be reported in the first half of 2026. This early clinical milestone positions BMF‑650 as a potential high‑value asset in the competitive obesity market and may enhance Biomea’s valuation and future funding prospects.
By moving BMF‑650 into clinical testing, Biomea demonstrates progress toward its goal of delivering disease‑modifying therapies for obesity and diabetes, potentially expanding its addressable market and providing a new revenue stream once approved. The milestone may also increase investor confidence and support future financing rounds.
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