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 2023

• The 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 period

• The 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 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 will also include an open label portion for adults with type 1 diabetes up to 15 years since diagnosis. The open label portion (n=40) 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 period.

"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."