Biomea Fusion Doses First Patient in 60-Subject Phase II Trials with Q4 2026 Readout
Biomea Fusion has dosed the first patient in its Phase II COVALENT-211 and COVALENT-212 trials of icovamenib in type 2 diabetes patients failing standard therapies. Each 60-patient study features a 12-week dosing period, a 40-week off-treatment durability assessment and a Week 26 primary endpoint readout slated for Q4 2026.
1. First Patient Dosed in Phase II Programs
Biomea Fusion has enrolled and dosed the first patient in its Phase II COVALENT-211 and COVALENT-212 trials of icovamenib, initiating targeted development in two distinct type 2 diabetes populations that have not achieved glycemic control on existing regimens.
2. Trial Design and Endpoints
Each study plans to enroll approximately 60 participants across 20 sites with a 2:1 randomization to icovamenib 100 mg daily or placebo. COVALENT-211 includes patients with HbA1c between 7.5% and 10.5% on one to three antidiabetic agents, while COVALENT-212 focuses on those with HbA1c 7.5%–9.5% on stable GLP-1 RA therapy; both have a 12-week dosing period and a 40-week off-treatment durability assessment.
3. Icovamenib Mechanism and Durability Data
Icovamenib inhibits menin to restore beta-cell function, building on COVALENT-111 results that showed placebo-adjusted HbA1c reductions of up to 1.8% maintained nine months after a 12-week course. The trials will assess primary glycemic control at Week 26 and durable beta-cell function through Week 52, with topline data expected in the fourth quarter of 2026.