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Biomea Fusion Announces FDA Clearance of Investigational New Drug (IND) Application for Covalent Menin Inhibitor BMF-219 in Type 2 Diabetes
COVALENT-111, a Phase I/II clinical trial in patients with type 2 diabetes, already underway in Canada, will now activate sites in the USAs previously
About this update from Biomea Fusion, Inc.
[{"type":"text","content":"COVALENT-111, a Phase I/II clinical trial in patients with type 2 diabetes, already underway in Canada, will now activate sites in the USAs previously reported, the Phase I portion of COVALENT-111 has been completed, with BMF-219 demonstrating a favorable safety, pharmacokinetics (PK) and pharmacodynamics (PD) profile Ongoing Phase II portion is evaluating BMF-219’s long-term glycemic control by restoring the pool and health of beta cells in type 2 diabetes patientsInitial data from the Phase II portion of the study is expected in the first half of 2023Company to host conference call on Thursday, December 15 at 4 PM EST featuring the BMF-219 clinical program in type 2 diabetes REDWOOD CITY, Calif., Dec. 14, 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 U.S. Food and Drug Administration (FDA) has cleared Biomea's IND application for BMF-219 in type 2 diabetes to support the expansion of the COVALENT-111 study to sites in the U.S. Biomea management will host a conference call on Thursday, December 15 at 4PM EST to provide an overview of the COVALENT-111 study, as well as further details on the role of menin in diabetes and BMF-219’s potentially disease-modifying impact on beta cell health. “We are excited to now clinically evaluate the impact that we have observed with BMF-219 in preclinical studies on the health of beta cells, which is critical to enabling patients with diabetes to naturally produce insulin. In animal models, BMF-219 has shown a very unique profile in preserving, reactivating and regenerating beta cells,” said Dr. Steve Morris, Chief Medical Officer. ”During my 40 years in medicine, I have not seen a more direct and elegant approach to addressing this root cause of diabetes.” “With this IND clearance for BMF-219, we have reached another critical milestone in our pursuit of providing an important new medicine to diabetes patients that addresses the underlying disease physiology. COVALENT-111 is a historic study, representing the first clinical evaluation of an orally administered, covalent small molecule directly targeting menin, a well-known regulator of bet...