other material
confidence high
sentiment positive
materiality 0.85
Biomea Fusion icovamenib Phase II meets primary endpoint; 1.47% HbA1c reduction in insulin-deficient T2D patients
Biomea Fusion, Inc.
- Best response in beta-cell deficient patients on antidiabetic agents: placebo-adjusted HbA1c reduction 1.47% at Week 26 (p=0.022) after 12 weeks dosing.
- Arm B (100mg QD for 12 weeks) showed mean HbA1c reduction of 0.5% (p=0.012) in per protocol patients on one or more baseline therapy.
- In insulin-deficient subtypes (SIDD/MARD), Arm B demonstrated mean HbA1c reduction of 1.05% (p=0.004).
- Icovamenib well-tolerated: no AE-related discontinuations, no hypoglycemic events, no related serious adverse events.
- Company plans to discuss data with FDA; 52-week readout anticipated in H2 2025.