Biomea Fusion reports 52-week Phase II COVALENT-111 data: HbA1c reductions up to 1.5% in severe insulin-deficient T2D

Biomea Fusion, Inc.

In severe insulin-deficient T2D patients (n=10), icovamenib achieved durable HbA1c reduction of 1.2% (p=0.01) through Week 52 after 12 weeks dosing.
Best result in Arm B (n=6): mean HbA1c reduction of 1.5% (p=0.01); no treatment-related serious adverse events.
In patients on GLP-1 therapy not at glycemic targets (n=11), icovamenib added 1.3% HbA1c reduction (p=0.05) sustained to Week 52.
Phase IIb trial (COVALENT-211) in severe insulin-deficient T2D expected to start Q4 2025; Phase II with GLP-1 (COVALENT-212) also Q4.
Food Effect Study (COVALENT-121) ongoing, expected completion by December 2025; oral GLP-1 RA (BMF-650) Phase I data anticipated H1 2026.

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