Biomea Fusion completes enrollment in Phase II diabetes trial

Biomea Fusion, Inc. (Nasdaq: BMEA) announced the completion of enrollment in COVALENT-211, a Phase II clinical trial evaluating icovamenib in patients with insulin-deficient type 2 diabetes (T2D) who remain inadequately controlled on standard-of-care antihyperglycemic therapies.

The trial enrolled 64 participants across 18 clinical sites. Participants were randomized 2:1 to receive either icovamenib 100 mg once daily or placebo for 12 weeks as an add-on to stable background therapy, followed by a 40-week off-treatment period. The primary endpoint will be assessed at Week 26, with secondary endpoint follow-up through Week 52. The company anticipates reporting topline Week 26 results in the first quarter of 2027.

Eligible participants were required to have HbA1c levels between 7.5% and 10.5% and a body mass index of 32 kg/m² or below, with a stable dose of one to three antihyperglycemic therapies for at least three months prior to screening.

A separate Phase II trial, COVALENT-212, is evaluating icovamenib in T2D patients not achieving glycemic targets despite GLP-1-based therapy. Enrollment in that trial remains ongoing, with completion expected before year-end and topline 26-week primary endpoint data anticipated in the second quarter of 2027.

Both trials build on findings from the Phase II COVALENT-111 trial, which reported placebo-adjusted HbA1c reductions of up to 1.5% at Week 52 in insulin-deficient T2D patients and up to 1.8% in a GLP-1 subgroup, measured off treatment. Increased C-peptide levels were also observed in both populations. No treatment-related serious adverse events or treatment discontinuations were reported during the 52-week observation period in that trial.

Icovamenib is an investigational oral small molecule in Phase 2 development for type 1 and type 2 diabetes. According to the company's press release, preclinical data suggest the compound promotes downmodulation of menin, a transcriptional regulator implicated in beta-cell biology.

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