Early Results from BMF-219 in Type 1 Diabetes Patients

Biomea Fusion, a clinical-stage biopharmaceutical firm, has reported promising early results from its Phase II study on a novel covalent menin inhibitor, BMF-219, intended for the treatment of diabetes. The drug is being tested for its capacity to regenerate insulin-producing beta cells, potentially offering a cure for diabetes.

The initial findings from the first two participants with type 1 diabetes in the COVALENT-112 trial are encouraging. Both individuals exhibited enhanced beta-cell function after initial treatment with BMF-219. The drug has been reported to be well tolerated, and the company anticipates the open label segment of the Phase II study, involving 40 type 1 diabetes patients dosed for 12 weeks, to be completed in 2024.

Additionally, a patient with type 2 diabetes who was administered BMF-219 for 4 weeks in the COVALENT-111 trial has shown improved blood sugar control after discontinuing metformin, a common diabetes medication, at week 40.

Juan Pablo Frias, Biomea Fusion’s Chief Medical Officer, expressed excitement over the initial response data, highlighting the potential of covalent inhibition of menin to regenerate beta cells and provide disease-modifying benefits. Dr. Tom Elliott, a key investigator in the study, noted the unprecedented immediate increases in C-peptide secretion observed with BMF-219, emphasizing the need for longer-term follow-up with more patients.

The COVALENT-112 study is a randomized, placebo-controlled, double-blind Phase II trial with 150 participants. It is designed to assess the safety, efficacy, and durability of BMF-219 in adults with type 1 diabetes within three years of diagnosis. The open label portion of the trial will also examine these factors in 40 adults with type 1 diabetes up to 15 years post-diagnosis.

The study showcases early response data from two patients with Stage 3 type 1 diabetes who received BMF-219. One case involved a 58-year-old with a 3-year diagnosis, who saw a significant increase in fasting C-peptide levels. The other case was a 24-year-old with a 7-year diagnosis, who experienced an increase in fasting C-peptide and a near-normal glucose response during a mixed-meal tolerance test without any meal-time insulin.

Dr. Alexander Abitbol, an endocrinologist and key investigator in both the type 1 and type 2 diabetes trials, shared his experience with patients who responded positively to BMF-219, with some even discontinuing their background antidiabetic medication post-study.

Diabetes is a chronic condition affecting blood sugar levels and can lead to severe health complications. The CDC predicts that about 40% of the adult U.S. population will develop diabetes in their lifetime, with over 37 million currently diagnosed. Diabetes is a significant economic burden on the U.S. healthcare system, with a quarter of healthcare costs spent on diabetes care.

Biomea Fusion is leveraging its FUSION™ System to develop a pipeline of next-generation covalent-binding small molecule medicines. The company's focus is on maximizing clinical benefits for patients, with the ultimate goal of curing diseases.

Diabetes is characterized by a loss of functional beta cell mass, which is crucial for insulin synthesis and secretion. Menin is believed to inhibit beta-cell turnover and growth, suggesting that its inhibition could lead to the regeneration of healthy beta cells. Biomea is exploring BMF-219 as a potential therapeutic approach to halt or reverse the progression of diabetes.

Biomea Fusion is committed to the discovery and development of oral covalent small molecules for metabolic diseases and genetically defined cancers. The company's covalent small molecules offer advantages such as greater target selectivity and the potential for a more durable response. Biomea Fusion aims to make a significant impact on disease treatment and patient care.