Biomea Fusion announces new preclinical findings from study of BMF-650

Biomea Fusion (BMEA) 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. Study Design and Key Preclinical Findings: Daily food intake was reduced to an average of 35g/day and 16g/day versus 109 g/day for the vehicle control group. BMF-650 induced rapid and durable weight loss during the study, with reductions of 12% and 15% from baseline at Day 28. BMF-650 was generally well tolerated, with no aminotransferase elevations. BMF-650 Preclinical Highlights: Goal to achieve a more patient-friendly dose escalation profile than current GLP-1 RAs. Demonstrated robust glycemic control and appetite suppression in multiple preclinical models resulting in pronounced and dose-dependent weight reduction. Generally well tolerated without safety concerns outside of the observed class effects. Next Steps: Investigational New Drug submission on track for the second half of 2025. Phase I trial in obese, otherwise healthy volunteers anticipated to begin in late 2025, subject to IND clearance. A full set of preclinical data for BMF-650 is planned for submission and presentation at an upcoming medical conference.