BMF-219 is a novel investigational covalent menin inhibitor developed to regenerate insulin-producing beta cells with the aim to cure diabetes Health Canada has cleared the initiation of COVALENT-112, a Phase II clinical trial of BMF-219 in adults living with type 1 diabetes (T1D), following FDA clearance of the initiation of COVALENT-112 in October 2023The randomized, double-blind, placebo-controlled (n=150) trial in adults living with T1D will 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 periodThe trial will also include an open label portion, enrolling participants in the US and Canada with T1D up to 15 years since diagnosis REDWOOD CITY, Calif., Dec.

05, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), 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, today 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. COVALENT-112 trial (n=150) will examine the safety, efficacy, and durability of BMF-219 in .