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

Icovamenib demonstrates durable efficacy and favorable safety profile in 52-week follow-up

Mar. 14, 2026 at 9:34am

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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 subgroups of severe insulin-deficient diabetes and patients on GLP-1-based therapy. Icovamenib maintained a favorable safety profile throughout the observation period.

Why it matters

The COVALENT-111 study results provide initial evidence of icovamenib's potential to transform the diabetes treatment landscape by effectively addressing the underlying beta cell dysfunction in type 2 diabetes. Addressing the unmet need in severe insulin-deficient diabetes, a subtype characterized by rapid disease progression and high risk of complications, is a key focus for Biomea Fusion.

The details

The COVALENT-111 study was a double-blind, randomized, placebo-controlled trial that enrolled adult patients with type 2 diabetes. The study evaluated icovamenib in three dosing regimens, with the 52-week analysis primarily focusing on patients who received 12 weeks of treatment. Among the severe insulin-deficient diabetes subgroup, icovamenib achieved a statistically significant HbA1c reduction of 1.5% at Week 52. The study also showed clinically meaningful glycemic improvement in participants receiving GLP-1-based therapy but had not achieved glycemic targets at study entry, with an HbA1c reduction of 1.2% at Week 52.

  • The 52-week follow-up data from the COVALENT-111 study was presented at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) on March 14, 2026.
  • The 26-week primary endpoint data from the Phase II COVALENT-211 and COVALENT-212 studies are anticipated in the fourth quarter of 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 presenter of the oral presentation at the ATTD conference highlighting the positive 52-week follow-up results from the COVALENT-111 study.

Mick Hitchcock, Ph.D.

The Interim CEO and Board Member of Biomea Fusion.

Centers for Disease Control and Prevention

The organization that reports that more than 38 million Americans (~11% of the population) have diabetes, and 98 million adults have prediabetes.

Ahlqvist algorithm

The algorithm used to prospectively evaluate outcomes by diabetes phenotype in the COVALENT-111 study.

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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

The company plans to initiate two new Phase II studies, COVALENT-211 and COVALENT-212, in the fourth quarter of 2026 to specifically address the patient populations that had the best responses in the COVALENT-111 trial.

The takeaway

The positive results from the COVALENT-111 study, particularly in the severe insulin-deficient diabetes subgroup and patients on GLP-1-based therapy, suggest icovamenib's potential to address the underlying beta cell dysfunction in type 2 diabetes and transform the treatment landscape for this chronic and debilitating condition.