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

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

Mar. 16, 2026 at 2:34pm

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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-based therapy. Icovamenib maintained a favorable safety profile throughout the observation period.

Why it matters

The results from the COVALENT-111 study suggest icovamenib's potential to transform the diabetes treatment landscape by effectively addressing the underlying biology of the disease. Severe insulin-deficient diabetes represents a high unmet medical need, and addressing the beta cell dysfunction in this population could help slow or potentially reverse disease progression.

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, and the 52-week analysis focused on patients who received 12 weeks of treatment. Among the severe insulin-deficient patients, icovamenib achieved a 1.2% reduction in HbA1c at Week 52, with the strongest performing arm showing a 1.5% reduction. The study also showed clinically meaningful glycemic improvement in participants on GLP-1-based therapy but had not achieved glycemic targets at study entry, with a 1.2% HbA1c reduction 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) in Barcelona 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 diabetes and obesity company developing oral small molecule therapies, including icovamenib and BMF-650.

Juan Pablo Frias, MD

The presenter of the COVALENT-111 study data at the ATTD conference.

Mick Hitchcock, Ph.D.

The Interim CEO and Board Member of Biomea Fusion.

U.S. Food and Drug Administration

The regulatory body that imposed a clinical hold on the COVALENT-111 study, which temporarily interrupted study dosing.

Centers for Disease Control and Prevention

The organization that reports on the prevalence and economic burden of diabetes in the United States.

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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.”

— Mick Hitchcock, Interim CEO and Board Member of Biomea Fusion (Biomea Fusion)

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 icovamenib's potential to address the underlying biology of diabetes, particularly in patients with severe insulin deficiency who represent a high unmet medical need. Biomea Fusion's upcoming Phase II studies will aim to build on these findings and further explore icovamenib's efficacy in targeted patient populations.