Biomea Fusion Inc. (NASDAQ: BMEA) announced it has dosed the first patient in two newly initiated Phase II clinical programs evaluating icovamenib in type 2 diabetes patients who have not responded to standard treatments.

The COVALENT-211 study enrolls insulin-deficient type 2 diabetes patients, while COVALENT-212 targets patients whose diabetes remains uncontrolled despite GLP-1 receptor agonist-based therapy. Both studies plan to enroll approximately 60 participants each across 20 clinical sites.

Participants will receive icovamenib 100 mg once daily or placebo for 12 weeks, followed by a 40-week off-treatment observation period. The company expects topline data from the 26-week primary endpoint for both studies in the fourth quarter of 2026.

The studies build on results from the Phase II COVALENT-111 trial, where icovamenib demonstrated sustained glycemic improvements nine months after a 12-week treatment course. In insulin-deficient patients, the drug achieved up to a 1.5% mean reduction in HbA1c compared to placebo, while patients on GLP-1 receptor agonist therapy showed a 1.8% reduction.

Icovamenib targets menin, a protein that regulates beta-cell function in the pancreas. The company's approach aims to restore beta-cell function, which deteriorates in diabetes patients and leads to insufficient insulin production.

For COVALENT-211, eligible participants must have HbA1c levels between 7.5% and 10.5% and a BMI of 32 kg/m² or lower. COVALENT-212 participants must have HbA1c levels between 7.5% and 9.5% and a BMI between 25 and 40 kg/m².

The clinical-stage diabetes company stated the studies address patient populations that would otherwise require insulin therapy as their next treatment option when existing therapies no longer provide adequate glucose control.