Biomea Fusion Presents Positive Phase II COVALENT-111 Data in Type 2 Diabetes

Icovamenib shows durable efficacy and favorable safety profile in patients with severe insulin-deficient diabetes and those on GLP-1 therapies

Mar. 14, 2026 at 8:48am

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Biomea Fusion, a clinical-stage diabetes and obesity company, announced positive 52-week follow-up results from its Phase II COVALENT-111 study evaluating the efficacy, safety, and tolerability of icovamenib in patients with type 2 diabetes. The study showed statistically significant and clinically meaningful reductions in HbA1c, particularly in patients with severe insulin-deficient diabetes and those on GLP-1 therapies. Icovamenib maintained a favorable safety profile throughout the 52-week observation period.

Why it matters

The results from the COVALENT-111 study suggest that icovamenib has the potential to transform the diabetes treatment landscape by effectively addressing the underlying beta cell dysfunction in patients with severe insulin-deficient diabetes, a population with significant unmet medical needs. Additionally, the positive data in patients on GLP-1 therapies indicates icovamenib could be a valuable addition to the treatment options for those who have not achieved glycemic targets.

The details

The COVALENT-111 study evaluated icovamenib in three dosing regimens: Arm A at 100mg QD (once daily) for 8 weeks, Arm B at 100mg QD for 12 weeks, and Arm C at 100 mg QD for 8 weeks and 100mg BID (twice daily) for 4 weeks. Among the severe insulin-deficient patients, icovamenib achieved an HbA1c reduction of 1.2% at Week 52, with the strongest performing arm being Arm B (100mg QD for 12 weeks) with a mean HbA1c reduction of 1.5%. The 52-week analysis also showed clinically meaningful glycemic improvement in study participants who were receiving a GLP-1-based therapy but had not achieved glycemic targets at study entry, with an HbA1c reduction of 1.2% at Week 52.

  • The COVALENT-111 study was conducted between 2024 and 2026.
  • The 52-week follow-up data was presented at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) on March 14, 2026.

The players

Biomea Fusion, Inc.

A clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies, icovamenib and BMF-650, for diabetes and obesity.

Juan Pablo Frías, MD

The researcher who delivered the oral presentation on the COVALENT-111 study results at the ATTD conference.

Mick Hitchcock, Ph.D.

The Interim CEO and Board Member of Biomea Fusion.

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What they’re saying

“We are encouraged by the durability of icovamenib's effect observed nine months post-dosing at Week 52. We believe that we now have in hand initial evidence of durable efficacy, additional favorable safety data, a clear understanding of an effective dose, and most importantly, the target patient populations. We believe icovamenib demonstrates potential to transform the diabetes treatment landscape by effectively addressing the underlying biology.”

— Mick Hitchcock, Ph.D., Interim CEO and Board Member of Biomea Fusion (Globe Newswire)

What’s next

Biomea Fusion plans to initiate two new Phase II studies, COVALENT-211 and COVALENT-212, in the fourth quarter of 2026 to further evaluate icovamenib in specific patient populations that had the best responses in the COVALENT-111 trial.

The takeaway

The positive results from the COVALENT-111 study suggest that icovamenib has the potential to be a transformative treatment for patients with type 2 diabetes, particularly those with severe insulin-deficient diabetes and those who have not achieved glycemic targets on GLP-1 therapies. These findings highlight the promise of targeting menin as a novel approach to address the underlying beta cell dysfunction in diabetes.