Biomea Fusion announces Health Canada Clearance of CTA for BMF-219

Biomea Fusion announced that Health Canada has cleared Biomea’s Clinical Trial Application, CTA, to study BMF-219 in adults living with type 1 diabetes. The objective of COVALENT-112 is to evaluate the safety, efficacy, and durability of BMF-219, a novel investigational 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 restore 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. “Our study COVALENT-111 is currently enrolling persons with type 2 diabetes and has generated tremendous enthusiasm among investigators in Canada. We are now looking forward to examining the potential of BMF-219 in persons with type 1 diabetes with our study COVALENT-112 in this region. BMF-219 is designed to target a root cause of diabetes, a depleted pool of beta cells. Insulin-producing beta cells are necessary to establish glycemic control and are especially vital for people living with type 1 diabetes. We are very excited to explore BMF-219’s potential not only in type 2 but now also in type 1 diabetes, to successfully restore the health and function of beta cells and re-establish the body’s own mechanism to produce insulin naturally again,” stated Juan Pablo Frias, MD, Biomea Fusion’s Chief Medical Officer. He further added, “The newly added open label study is designed to enroll 40 adults living with type 1 diabetes at two different dose levels. We expect it will provide valuable insights early on to inform and apply learnings to the randomized blinded portion of the trial.”