Biomea Fusion Highlights Initial Data From The First Two Type 1 Diabetes Patients Dosed With BMF-219

Author: Benzinga Newsdesk | April 01, 2024 09:04am

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." 

COVALENT-112 is a randomized, placebo-controlled, double-blind Phase II study (n=150) designed to 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 includes an open label portion for adults with type 1 diabetes up to 15 years since diagnosis. The open label portion (n=40) will also 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.

We are highlighting initial response data from a data cut-off of March 7, 2024 from our first two patients with Stage 3 type 1 diabetes who have received BMF-219 in the open-label portion of COVALENT-112

Case Study Patient 1 Highlights

• A 58-year-old, diagnosed with type 1 diabetes 3 years ago
• BMF-219 200 mg once-daily
• Week 4: Fasting C-peptide increased by 57% compared to Baseline (study Day 1). During a mixed-meal tolerance test (MMTT) the C-Peptide Index (AUC) increased by 12%. The C-peptide index is the ratio of serum C-peptide to plasma glucose levels and is used to evaluate β-cell function
• Week 8: Fasting C-peptide increased by 80% compared to Baseline. During a MMTT, C-peptide increased up to 200%. The C-Peptide Index (AUC) increased by 40% compared to Baseline
• Data on any changes in daily insulin usage are pending
   

Case Study Patient 2 Highlights

• A 24-year-old, diagnosed with type 1 diabetes 7 years ago
• BMF-219 100 mg once-daily
• Week 4: Fasting C-peptide increased by 16% compared to Baseline. During a MMTT the C-peptide Index (AUC) increased by 30%
• Patient had a near-normal glucose response during the MMTT without receiving any meal-time insulin
• Patient had a reduction in daily insulin usage during the first four weeks of the study
   

Dr. Alexander Abitbol, Endocrinologist & Assistant Medical Director at the LMC Healthcare (Ontario, Canada), a key investigator in the type 2 diabetes COVALENT-111 study, and also participating in the type 1 diabetes COVALENT-112 study, provided further color on his experience with the follow-up of his patients after completion of the 26-week COVALENT-111 study, "The majority of my patients responded to 4 weeks of BMF-219 and continued to see an improvement in A1c over time. Some patients have now completed the 26-week study, and I am pleased to report that I recently discontinued a former study patient's background antidiabetic medication. This patient is doing particularly well and had an additional 1% HbA1c reduction after he completed the study. It has been exciting to participate in this study and explore this new pathway for the benefit of our patients. I look forward to continuing the enrollment."

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