other material
confidence high
sentiment positive
materiality 0.70
Biomea BMF-650 Phase 1: 1.5-3.2% weight loss in Cohorts 1-4 vs 0.1% placebo; Cohort 5 6.1% confounded
Biomea Fusion, Inc.
- Mean Day 29 weight reduction 1.5% to 3.2% across MAD Cohorts 1-4 (200 mg+ QD) vs 0.1% pooled placebo; weekly loss ~0.97 kg at 200 mg or higher.
- Cohort 5 (200 mg x1 wk then 400 mg x3 wks) showed 6.1% (6.2 kg) mean weight loss at Day 29 but confinement cut placebo food intake to ~33%; results interpreted separately.
- Safety: across 5 active MAD cohorts (n=40) all TEAEs mild/moderate; no severe/serious TEAEs, no dose modifications or discontinuations; no ALT/AST increases.
- Cohort 5 GI events: nausea and vomiting each 12.5%, constipation 25%, diarrhea 0%; all Grade 1. Across all active cohorts: nausea 17.5%, vomiting 7.5%, constipation 10%, diarrhea 5%.
- BMF-650 needs longer-term toxicology studies; Biomea seeks strategic partnership/licensing; primary focus remains icovamenib in type 1 and type 2 diabetes.