US FDA Approves Biomea Fusion's IND Application For BMF 219

The FDA has approved Biomea's IND application to study BMF-219 in adults with type 1 diabetes, according to Biomea Fusion, Inc., 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. The objective of COVALENT-112 is to evaluate the safety, efficacy, and durability of BMF-219, a covalent menin inhibitor, in potentially restoring beta cell function. Beta cell loss is a root cause of type 1 and type 2 diabetes. Menin inhibition has been demonstrated to improve beta cell function.

Preclinical studies have shown the potential of BMF-219 to specifically regenerate and retain insulin-producing beta cells in animal models of type 1 and type 2 diabetes, as per pharmabiz. “We are excited to evaluate the potential impact BMF-219 may have in people with type 1 diabetes. Currently, the only available therapy for these patients is exogenous insulin which requires intensive management with chronic multiple daily insulin injections or treatment with an insulin pump, and has a risk of hypoglycemia, increased morbidity and mortality,” stated Juan Pablo Frias, MD, Biomea Fusion’s CMO.

He added, “By targeting one of the root causes of diabetes, we may successfully restore the health and function of the body’s own mechanism to produce insulin, the beta cells. I’m excited for patients as BMF-219 has shown a significant ability to regenerate and retain those critical cells in preclinical and early-phase clinical studies in type 2 diabetes.”