Biomea Fusion announced topline results from its Phase 1 clinical trial (GLP-131) for BMF-650, an investigational oral GLP-1 receptor agonist for obesity. The drug demonstrated consistent weight reduction over four weeks and an encouraging safety and tolerability profile, notably with low rates of gastrointestinal side effects.
Key Details
- Efficacy: Participants in outpatient cohorts (1-4) showed a mean weight reduction ranging from 1.5% to 3.2% at Day 29, compared to a 0.1% reduction for the placebo group.
- Safety Profile: No severe or serious treatment-emergent adverse events (TEAEs) were reported across all BMF-650-treated participants. All TEAEs were mild or moderate, with no discontinuations due to adverse events.
- Tolerability: The drug showed a favorable gastrointestinal profile, with nausea reported in 17.5% and vomiting in 7.5% of participants across all active cohorts. A rapid one-step titration to the target 400 mg dose was well-tolerated.
- Next Steps: The company plans to conduct longer-term toxicology studies and is positioning the BMF-650 program for a strategic partnership to support late-stage development.