Biomea Fusion, Inc. 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. The company 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.

The newly added open label study is designed to enroll 40 adults living with type 1 diabetes at two different dose levels. The company expects it will provide valuable insights early on to inform and apply learnings to the randomized blinded portion of the trial. The open label portion (n=40) will examine the safety, efficacy, and durable of BMF-219 at two oral dose levels, 100 mg and 200 mg for 12-we weeks of treatment followed by a 40 week off-treatment period.