Icovamenib (BMF-219) with a GLP-1-Based Therapy - (COVALENT-211)

Aug. 24, 2026: Biomea Fusion (NASDAQ: BMEA) said it completed enrollment in COVALENT-211, a randomized, double-blind, placebo-controlled Phase II trial of icovamenib in insulin-deficient type 2 diabetes patients inadequately controlled on standard antihyperglycemic therapy. The study enrolled 64 patients at 18 sites, randomized 2:1 to icovamenib 100 mg once daily or placebo for 12 weeks, with a 40-week off-treatment follow-up. The primary endpoint is at Week 26, with topline primary-endpoint data expected in Q1 2027 and secondary follow-up through Week 52.

COVALENT-212, a separate Phase II trial in T2D patients inadequately controlled despite GLP-1-based therapy, remains enrolling, with completion expected before year-end 2026 and topline Week 26 primary-endpoint data expected in Q2 2027.

The company said both trials were designed based on Phase II COVALENT-111 findings. In a 52-week analysis from COVALENT-111, icovamenib produced up to a placebo-adjusted 1.5% mean HbA1c reduction at Week 52 in severe insulin-deficient T2D patients (p=0.01) and up to a 1.8% placebo-adjusted mean HbA1c reduction at Week 52 in a GLP-1 RA-based therapy subgroup (p=0.05). Increased off-treatment C-peptide levels were reported in both groups, and icovamenib was generally well tolerated with no treatment-related serious adverse events or discontinuations during the 52-week observation period.