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Biomea Fusion Announces First Patient Dosed in Newly Initiated Phase II Programs Enrolling Type 2 Diabetes Patients Failing on Standard-of-Care Therapies
COVALENT-211 Phase II enrolling insulin-deficient type 2 diabetes patients COVALENT-212 Phase II enrolling type 2 diabetes patients uncontrolled with a GLP-1
About this update from Biomea Fusion, Inc.
[{"type":"text","content":"COVALENT-211 Phase II enrolling insulin-deficient type 2 diabetes patients COVALENT-212 Phase II enrolling type 2 diabetes patients uncontrolled with a GLP-1 receptor agonist-based therapyTopline 26-week primary endpoint data from both Phase II studies anticipated 4Q 2026 SAN CARLOS, Calif., March 31, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced that the first patient has been dosed in its newly initiated Phase II programs, COVALENT-211 and COVALENT-212, evaluating icovamenib in patients with type 2 diabetes (“T2D”), marking a key step in advancing icovamenib into Phase II development in targeted patient populations failing standard-of-care therapies as established in the clinical trial COVALENT-111. “These studies represent an important step forward as we advance icovamenib into later-stage Phase II development in the two clearly defined patient populations in which we had observed sustained glycemic improvements in our prior study. We are planning to enroll these two studies within the second quarter to achieve an initial readout before year-end.” said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. “The design of COVALENT-211 and COVALENT-212 is informed by the durability, safety profile, and subgroup responses observed in our Phase II COVALENT-111 study, where we saw clinically meaningful glycemic improvements following a limited 12-week course of therapy with effects sustained nine months post the dosing period. These studies address patients who would otherwise require insulin therapy as one of their next therapeutic choices while existing alternatives are no longer providing glucose control. We believe icovamenib can provide significant benefits to these patients.” Icovamenib’s Phase II Diabetes Program - COVALENT-211 and COVALENT-212 COVALENT-211 (NCT07502495) is evaluating icovamenib in adult patients with insulin-deficient T2D who are not achieving glycemic targets despite antihyperglycemic medications. Eligible participants must be on a stable dose of one to three antidiabetic therapies for at least three months prior to screening, with HbA1c levels between 7.5% and 10.5% and a body mass index (BMI) of ≤32 kg/m². Icovamenib is administered as ...