Biomea Fusion Announces Phase 1 Results for BMF-650, its Investigational Next-Generation Oral Small Molecule GLP-1 Receptor Agonist
Biomea Fusion announced Phase 1 results for BMF-650, its oral small-molecule GLP-1 receptor agonist, with Day 29 weight reduction of 1.5% to 3.2% in outpatient Cohorts 1-4 versus 0.1% for pooled placebo. All treatment-emergent adverse events across the 40 active-dose participants were mild or moderate, with no severe or serious TEAEs or TEAE-related discontinuations, and a one-step titration to 400 mg QD was well tolerated with nausea and vomiting each in 12.5% of Cohort 5 participants.
Key figures
- Drug Name
- BMF-650
- Phase Of Trial
- Phase 1
- Target dose
- 400 mg QD after one-week titration
- Cohort5 nausea
- 12.5%
- Cohort5 vomiting
- 12.5%
- All cohorts nausea
- 17.5%
- All cohorts vomiting
- 7.5%
- Cohort5 constipation
- 25%
- Active mad participants
- 40
- Cohort5 day29 weight reduction
- 6.1% (6.2 kg), also observed in placebo patients
- Day29 weight reduction range outpatient
- 1.5%-3.2% (Cohorts 1-4) vs 0.1% placebo
- Weekly weight reduction cohorts1 4 200mg plus
- approximately 0.97 kg
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