Biomea Fusion Presents Phase II COVALENT-111 Data in Type 2 Diabetes at the 19th International Conference on Advanced Technologies & Treatments for Diabetes 2026

SAN CARLOS, Calif., March 14, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea,” “Biomea Fusion,” or the “Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced that Juan Pablo Frías, MD, delivered an oral presentation at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (“ATTD”) in Barcelona on March 14, 2026 highlighting positive 52-week follow-up results from the Company’s Phase II COVALENT-111 study evaluating the efficacy, safety, and tolerability of icovamenib in patients with type 2 diabetes (“T2D”).

“We are encouraged by the durability of icovamenib’s effect observed nine months post-dosing at Week 52,” said Mick Hitchcock, Ph.D., Interim CEO and Board Member of Biomea Fusion. “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. We are excited about the upcoming two new Phase II studies which are designed to specifically address those patients that had the best responses in our trial COVALENT-111.”

COVALENT-111 Study Design and Results
COVALENT-111 was a double-blind, randomized, placebo-controlled trial that enrolled adult patients diagnosed with T2D within the last seven years. Eligible participants had HbA1c levels between 7.0% and 10.5%, and a body mass index (“BMI”) between 25 and 40 kg/m². At baseline, all participants were treated with lifestyle management, including diet and exercise, with or without antidiabetic medications and had inadequate glycemic control despite treatment with up to three antidiabetic medications.

The 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. A total of 267 patients received at least one dose of icovamenib and were considered evaluable for the modified intent-to-treat population. As previously reported, study dosing was temporarily interrupted due to a clinical hold imposed by the U.S. Food and Drug Administration. The topline efficacy analysis presented here includes the patient population (N=163) who had completed at least 80% of their planned dosing prior to the clinical hold (without other significant protocol deviations) and who, at baseline, were treated with one or more antihyperglycemic agents. As prespecified in the statistical analysis plan, outcomes were prospectively evaluated by diabetes phenotype using the Ahlqvist algorithm.