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

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

Mar. 14, 2026 at 11:00am

Got story updates? Submit your updates here. ›

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 beta cell dysfunction, a core component of diabetes progression. Addressing the unmet need in severe insulin-deficient diabetes, a subtype characterized by rapid disease progression and high risk of complications, could be a significant opportunity for icovamenib.

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 showed positive results through Week 52 across multiple subgroups. In the severe insulin-deficient diabetes subgroup, icovamenib achieved a statistically significant HbA1c reduction of 1.2% at Week 52, with the strongest performing arm seeing a 1.5% reduction. Icovamenib also demonstrated 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 a 1.2% HbA1c reduction at Week 52. Icovamenib maintained a favorable safety profile throughout the 52-week observation period.

  • The COVALENT-111 study was a 52-week follow-up trial.
  • The 52-week analysis 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 diabetes and obesity company developing oral small molecule therapies, including icovamenib and BMF-650.

Juan Pablo Frías, MD

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

Mick Hitchcock, Ph.D.

The Interim CEO and Board Member of Biomea Fusion.

Got photos? Submit your photos here. ›

What they’re saying

“We are encouraged by the durability of icovamenib's effect observed nine months post-dosing at Week 52.”

— 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 icovamenib's potential to address the underlying beta cell dysfunction in type 2 diabetes, particularly in the severe insulin-deficient diabetes subtype, which represents a significant unmet medical need. Biomea Fusion's upcoming Phase II studies will further explore icovamenib's efficacy in targeted patient populations.