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Biomea Fusion Announces Dosing of First Patient with Type 2 Diabetes and Completion of Phase I Healthy Volunteer Portion of Phase I/II (COVALENT-111) Study of BMF-219
BMF-219 is the first menin inhibitor to reach the clinic for type 2 diabetes. The Phase II portion of COVALENT-111 is designed to examine the capacity of
About this update from Biomea Fusion, Inc.
[{"type":"text","content":"BMF-219 is the first menin inhibitor to reach the clinic for type 2 diabetes. The Phase II portion of COVALENT-111 is designed to examine the capacity of BMF-219 to provide long-term glycemic control by restoring the patient’s pool of beta cellsBeta cell loss is a critical component of the etiology and pathogenesis of type 1 and type 2 diabetes; menin is thought to function as the brakes on beta cell recovery in the pancreas. BMF-219 was designed to specifically inhibit menin. Preclinical studies have shown the potential of BMF-219 to restore functional beta cellsThe Phase I portion of COVALENT-111 in healthy volunteers is now completed and was designed to assess safety, tolerability, and pharmacokinetics; BMF-219 was well tolerated and showed a favorable PK and PD profileThe study is ongoing following clearance of the CTA by Health Canada; alignment has been reached with the FDA on the contents of the IND, filing is on track for Q4 to support expansion of COVALENT-111 to U.S. sites, subject to FDA clearanceInitial data from the Phase II portion of the study is expected in the first half of 2023 REDWOOD CITY, Calif., Oct. 31, 2022 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, today announced the dosing of the first patient with type 2 diabetes in the Phase II portion of COVALENT-111, a Phase I/II clinical trial underway in Canada. Biomea has completed the Phase I portion of the trial in healthy volunteers. “With the dosing of our first patient with BMF-219, we have reached an important milestone for the nearly 500 million patients worldwide with type 2 diabetes. We are pursuing BMF-219 with the aim to cure this disease. Beta cell preservation, reactivation and regeneration are the core components in providing diabetes patients with long term benefit,” stated Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board. “The burden of diabetes is rapidly increasing, and we are faced with a global unmet need for treatments with novel mechanisms of action. With BMF-219, a potentially first-in-class, covalent menin inhibitor, we are aiming to address and reverse the root cause of th...