Biomea Fusion Reports Preclinical Data for BMF-650, a Next-Generation Oral GLP-1 Receptor Agonist Candidate, Demonstrating Robust Weight Loss and Appetite Suppression in Obese Non-Human Primates
- Dose-dependent, marked reductions in food intake and significant weight loss observed in obese cynomolgus monkeys
- BMF-650 compared favorably to published data of a leading GLP-1 RA candidate
- IND filing on track for the second half of 2025; with Phase I study initiation in obese, otherwise healthy volunteers anticipated late 2025
Excerpt from the Press Release:
REDWOOD CITY, Calif., June 18, 2025 (GLOBE NEWSWIRE) — Biomea Fusion, Inc. (“Biomea,” “Biomea Fusion” or the “Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced new preclinical findings from a 28-day weight loss study in obese non-human primates evaluating BMF-650, the Company’s investigational, next-generation oral small molecule glucagon-like peptide-1 receptor agonist (GLP-1 RA).
The weight reduction study was conducted in 15 obese cynomolgus monkeys. The study demonstrated a clear, dose-dependent reduction in daily food intake and pronounced and continuous weight loss over a 28-day treatment period. BMF-650 was administered orally once daily at 10 mg/kg and 30 mg/kg and resulted in marked reductions in food intake and progressive body weight reductions, with the respective dose groups achieving a 12% and 15% average weight reduction from baseline over 28 days. These effects compared favorably to published preclinical data of another leading oral GLP-1 RA candidate in development.
“These new findings are especially relevant given the functional similarities between monkey and human GLP-1 receptors. These data disclosed today further support our goal of developing a next-generation oral GLP-1 receptor agonist with enhanced pharmacokinetic properties, specifically a more consistent plasma exposure and improved bioavailability, while preserving the potent metabolic effects observed with injectable therapies,” said Thorsten Kirschberg, Executive Vice President of Chemistry at Biomea and program lead for BMF-650.
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