Biomea Fusion Announces Dosing of First Patient with Type 2 Diabetes & Completion of Phase 1 Healthy Volunteer Portion of Phase 1/2 Study

Biomea Fusion, Inc. recently announced the dosing of the first patient with type 2 diabetes in the Phase 2 portion of COVALENT-111, a Phase 1/2 clinical trial underway in Canada. Biomea has completed the Phase 1 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,” said 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. We leveraged an opportunity to begin clinical development earlier by initiating the COVALENT-111 study in Canada. With the completion of the Phase 1 portion in healthy volunteers, we have now swiftly progressed to dosing type 2 diabetes patients in the Phase 2. 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 2 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, added “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 1/2 study. In the Phase 1 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 2 consists of multiple ascending dose cohorts and includes adult patients with type 2 diabetes uncontrolled by current therapies.

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.

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.