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Biomea Fusion Obtains FDA Clearance for Investigational New Drug (IND) Application for BMF-219 in Type 1 Diabetes

Friday, October 06, 2023

Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company specializing in the development of novel covalent small molecules for genetically defined cancers and metabolic diseases, has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to investigate BMF-219 in adults diagnosed with type 1 diabetes.

The primary goal of the COVALENT-112 study is to assess the safety, effectiveness, and long-term effects of BMF-219, a covalent menin inhibitor, in potentially restoring beta cell function. Beta cell loss plays a fundamental role in both type 1 and type 2 diabetes. Studies have shown that menin inhibition has the potential to improve beta cell function, and preclinical research indicates that BMF-219 may regenerate and preserve insulin-producing beta cells in animal models of diabetes.

Dr. Juan Pablo Frias, Chief Medical Officer at Biomea Fusion, expressed enthusiasm for the potential impact of BMF-219 on individuals with type 1 diabetes. He highlighted the limitations of current therapies and the potential of BMF-219 to address the underlying causes of diabetes by restoring beta cell health and insulin production.

Additionally, Thomas Butler, CEO and Chairman of the Board at Biomea Fusion, emphasized the company's commitment to exploring BMF-219's potential in various types of diabetes. He announced the expansion of their Phase I/II study for type 2 diabetes and shared the FDA's clearance for BMF-219 research in type 1 diabetes, leading to the initiation of the COVALENT-112 study. Butler expressed pride in achieving these milestones ahead of schedule and anticipation for upcoming study results.

COVALENT-112 is a Phase II trial for adults diagnosed with stage 3 type 1 diabetes, focusing on the period following clinical diagnosis when beta cell loss is significant. The study will compare two different BMF-219 doses with a placebo control to evaluate safety, tolerability, and efficacy. Approximately 150 patients will participate, receiving either BMF-219 or placebo for 12 weeks, followed by a 40-week "off-treatment" phase.

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