Biomea Fusion Highlights Initial Data from the First Two Type 1 Diabetes Patients Dosed with BMF-219

BMF-219 is an investigational novel covalent menin inhibitor developed to regenerate insulin-producing beta cells with the aim to cure diabetes

• The first two type 1 diabetes patients enrolled in COVALENT-112 both demonstrated early signs of clinical activity with improved measures of beta-cell function after initial treatment with BMF-219
• BMF-219 has been well tolerated by both patients
• Open label portion of Phase II COVALENT-112 study readout of 40 patients with type 1 diabetes dosed for 12 weeks with BMF-219 expected in 2024
• First type 2 diabetes patient dosed with BMF-219 for 4 weeks in COVALENT-111 being taken off background therapy (metformin) after week 40, displaying improved glycemic control

REDWOOD CITY, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, today announced initial response data from the first two type 1 diabetes patients treated with BMF-219 in the ongoing Phase II study (COVALENT-112).

“We are very excited to announce the initial response data from the first two type 1 diabetes patients enrolled in the COVALENT-112 study. Both patients showed improvement in measures of beta-cell function after only 4 weeks of dosing with BMF-219. We are rapidly gathering significant proof points we believe validate that covalent inhibition of menin leads to the regeneration of beta cells which has been shown to provide disease-modifying patient benefits,” stated Juan Pablo Frias, MD, Biomea Fusion’s Chief Medical Officer. “With BMF-219, we are learning about the potential of restoring the health and function of the beta cell pool in persons with diabetes and how this may lead to the restoration of the ability to produce and secrete insulin, and control blood glucose. These data are preliminary and we look forward to building upon them as we continue enrollment in the open-label portion of COVALENT-112.”

Dr. Tom Elliott, Medical Director of BC Diabetes (Vancouver, Canada), Clinical Associate Professor of Medicine at the UBC Division of Endocrinology, and a key investigator in the type 1 COVALENT-112 study added, “In my 32 years of practice as an endocrinologist I have never before seen a type 1 diabetes agent achieve such immediate increases in C-peptide secretion.  We need longer-term follow up in a greater number of patients to validate these early signals, but I am very excited for the potential BMF-219 may provide for people with type 1 and type 2 diabetes. This is an unparalleled opportunity to address the root cause of diabetes.”