Biomea Fusion advances diabetes drug trials in 2026

Biomea Fusion Inc. (NASDAQ: BMEA) outlined its development priorities for 2026, focusing on advancing two investigational drugs for diabetes and obesity treatment. The clinical-stage biopharmaceutical company plans to initiate two Phase II trials for icovamenib and continue development of BMF-650.

The company completed a food-effect study for icovamenib in 60 participants during the fourth quarter of 2025, establishing that the drug achieves optimal exposure when administered within 30 minutes after a meal. Biomea also completed chronic toxicology studies for icovamenib in two species, with more than 400 subjects having received the drug to date.

Icovamenib is designed as a covalent menin inhibitor targeting beta-cell proliferation and function in diabetes patients. The company reported 52-week data showing sustained glycemic improvement in insulin-deficient type 2 diabetes patients following a 12-week dosing period.

Biomea plans to begin enrollment in two Phase II studies in the first quarter of 2026. COVALENT-211 will evaluate icovamenib in approximately 60 patients with insulin-deficient type 2 diabetes, while COVALENT-212 will test the drug in about 60 type 2 diabetes patients inadequately controlled on GLP-1-based therapies. Both trials aim to measure HbA1c reduction over 26 weeks, with results expected in the fourth quarter of 2026.

The company is also developing BMF-650, an oral GLP-1 receptor agonist for obesity treatment. Initial 28-day weight loss data from a Phase I study in obese volunteers is expected in the second quarter of 2026.

"We believe icovamenib has the potential to redefine the treatment for insulin-deficient diabetes and those type 2 diabetes patients currently failing on GLP-1 therapies," said Mick Hitchcock, interim chief executive officer.

The information is based on a company press release statement.

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