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Biomea Fusion Announces FDA Clearance of Investigational New Drug (IND) Application for BMF-219 in Type 1 Diabetes

BMF-219 is a novel covalent menin inhibitor designed to regenerate insulin-producing beta cells with the aim to cure type 1 diabetes

  • The FDA has cleared the initiation of COVALENT-112, a Phase II clinical trial of BMF-219 in adults with type 1 diabetes (T1D).
  • The randomized, double-blind, placebo-controlled (N=150) trial in adults with T1D will examine the safety and efficacy of BMF-219 at two oral dose levels, 100 mg and 200 mg unfed, for 12-weeks of treatment followed by a 40 week off-treatment period.

Excerpt from the Press Release:

REDWOOD CITY, Calif., Oct. 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 the U.S. Food and Drug Administration (FDA) has cleared Biomea’s IND application to study BMF-219 in adults with type 1 diabetes.

The objective of COVALENT-112 is to evaluate the safety, efficacy, and durability of BMF-219, a 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 improve 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.

“We are excited to evaluate the potential impact BMF-219 may have in people with type 1 diabetes. Currently, the only available therapy for these patients is exogenous insulin which requires intensive management with chronic multiple daily insulin injections or treatment with an insulin pump, and has a risk of hypoglycemia, increased morbidity and mortality,” stated Juan Pablo Frias, MD, Biomea Fusion’s Chief Medical Officer. He added, “By targeting one of the root causes of diabetes, we may successfully restore the health and function of the body’s own mechanism to produce insulin, the beta cells. I’m excited for patients as BMF-219 has shown a significant ability to regenerate and retain those critical cells in preclinical and early-phase clinical studies in type 2 diabetes.”

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