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Biomea Fusion Announces Dosing of First Patient with Type 2 Diabetes in the United States in Ongoing Phase I/II (COVALENT-111) Study of BMF-219
COVALENT-111, now underway in the US, has completed Phase I and is currently enrolling type 2 diabetes patients in the Phase II randomized, placebo-controlled
About this update from Biomea Fusion, Inc.
[{"type":"text","content":"COVALENT-111, now underway in the US, has completed Phase I and is currently enrolling type 2 diabetes patients in the Phase II randomized, placebo-controlled portion of the trialBMF-219, an orally available covalent menin inhibitor, is being evaluated for its potential to enable the proliferation, preservation, and reactivation of healthy, functional beta cells capable of producing insulin, thereby leading to long-term glycemic controlDisease modification via the restoration of healthy beta cells in patients with type 2 diabetes would potentially address a root cause of the diseaseInitial Phase II data from this trial is expected in the first half of 2023 REDWOOD CITY, Calif., Jan. 04, 2023 (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 dosing of the first patient with type 2 diabetes in the Phase II portion of COVALENT-111 in the U.S. This trial is a randomized, double-blinded, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of six dose levels of BMF-219 administered orally daily in 28-day cycles followed by a 26-week evaluation period. “We are thrilled to announce this milestone so soon after receiving IND clearance from the FDA in December. BMF-219 is potentially capable of addressing and modifying a major driver of type 2 diabetes, beta cell health and function. We believe that this oral agent has the potential to obviate the need for multiple concurrent treatments, including insulin injections,” stated Thomas Butler, Biomea Fusion’s Chief Executive Officer, and Chairman of the Board. “We look forward to presenting initial data from the Phase II portion of COVALENT-111 later this year as we march toward our goal of delivering a transformational therapy for patients with diabetes.” Beta cells in the pancreas are responsible for producing, storing, and releasing insulin. Adequate insulin production helps ensure glucose homeostasis. Menin is thought to function as the brake and a key regulator for beta cell growth in the pancreas, acting as a checkpoint, to prevent excessive beta cell proliferation in healthy individual...