Biomea Fusion, Inc. announced dosing of the first patient with type 1 diabetes in the U.S. in its ongoing Phase II study (COVALENT-112) evaluating BMF-219, a novel, investigational covalent menin inhibitor, as a potential treatment for patients with type 1 diabetes. The objective of COVALENT-112 is to evaluate the safety, efficacy, and durability of BMF-219 in potentially restoring beta cell function in adults with type 1 diabetes. Beta cell loss is thought to be 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 proliferate insulin-producing beta cells in animal models of type 1 and type 2 diabetes. The randomized, placebo-controlled, double-blind portion of the COVALENT-112 trial (n=150) will examine the safety, efficacy, and durability of BMF-219 in adults diagnosed with type 1 diabetes within 3 years at two oral dose levels, 100 mg and 200 mg, for 12 weeks of treatment followed by a 40 week off-treatment period.

The trial includes an open label portion for adults with type 1 diabetes up to 15 years since diagnosis. The open label portion (n=40) will also examine the safety, efficacy, and durability of BMF-219 at two oral dose levels, 100 mg and 200 mg, for 12 weeks of treatment followed by a 40 week off-treatment period.