- 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 cells
- Beta 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 cells
- The 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 profile
- The 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 clearance
- Initial 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 this epidemic.”
Mr. Butler continued, “We leveraged an opportunity to begin clinical development earlier by initiating the COVALENT-111 study in Canada. With the completion of the Phase I portion in healthy volunteers, we have now swiftly progressed to dosing type 2 diabetes patients in the Phase II. In the meantime, we have been in active discussions with the FDA and plan to file an IND before the end of the year. We expect to report initial Phase II data in the first half of 2023.”
Rohit N. Kulkarni MD, PhD, Senior Investigator and Margaret A Congleton Professor; Section Head, Islet Cell and Regenerative Biology; and Professor of Medicine, Harvard Medical School, commented: “Based on the promising preclinical data presented at the European Association for the Study of Diabetes in September of this year, showing BMF-219’s ability to restore and balance beta cell mass in two distinct animal models of type 2 diabetes, it is very exciting to now see BMF-219 being evaluated in type 2 diabetes patients. While the importance of menin in beta cell biology was researched academically, we have not seen menin being clinically inhibited in type 2 diabetes patients. I am very excited to see a novel menin inhibitor, designed to address a key pathway to beta cell regeneration, advance into clinical development for the first time.”
COVALENT-111 is a multi-site, randomized, double-blind, placebo-controlled Phase I/II study. In the Phase I portion of the trial, healthy subjects were enrolled in single ascending dose cohorts to ensure safety at the prospective dosing levels for type 2 diabetic patients. Phase II consists of multiple ascending dose cohorts and includes adult patients with type 2 diabetes uncontrolled by current therapies.
About Menin in Diabetes
Loss of functional beta cell mass is a core component of the natural history in both types of diabetes — type 1 diabetes (mediated by autoimmune dysfunction) and type 2 diabetes (mediated by metabolic dysfunction). Beta cells are found in the pancreas and are responsible for the synthesis and secretion of insulin. Insulin is a hormone that helps the body use glucose for energy and helps control blood glucose levels. In patients with diabetes, beta cell mass and function are diminished, leading to insufficient insulin secretion and hyperglycemia. Menin is thought to act as a brake on beta-cell turnover and growth, supporting the notion that inhibition of menin could lead to the regeneration of normal, healthy beta cells. Based on these and other scientific findings, Biomea is exploring the potential for BMF-219-mediated menin inhibition as a viable therapeutic approach to permanently halt or reverse progression of type 2 diabetes.
About Biomea Fusion
Biomea Fusion is a clinical stage biopharmaceutical company focused on the discovery and development of covalent small molecules to treat patients with genetically defined cancers and metabolic diseases. A covalent small molecule is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional non-covalent drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response. The company is utilizing its proprietary FUSION™ System to advance a pipeline of covalent-binding therapeutic agents against key oncogenic drivers of cancer and metabolic diseases. Biomea Fusion’s goal is to utilize its capabilities and platform to become a leader in developing covalent small molecules in order to maximize the clinical benefit when treating various cancers and metabolic diseases.
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