- Biomea to present two oral abstracts across multiple animal models highlighting the ability of BMF-219, a covalent menin inhibitor, to significantly lower HbA1C (approximately two-fold greater reduction than active control, liraglutide) and to increase beta cell function.
- BMF-219 showed prolonged glycemic control in two standard diabetes animal models, the Zucker Diabetic Fatty (ZDF) and Streptozotocin-induced (STZ) Rat models, throughout the dosing period and, additionally, glycemic control was maintained after the dosing period ended.
- Oral Presentations to include additional data not released in the two posters presented at the American Diabetes Association Scientific Sessions on June 4, 2022.
- Biomea expects to initiate a Phase I/II clinical trial of BMF-219 in type 2 diabetes in the second half of 2022, subject to IND submission and clearance.
REDWOOD CITY, Calif., July 01, 2022 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (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, announced today that two BMF-219 preclinical abstracts were chosen for oral presentations at the European Association for the Study of Diabetes (EASD) Annual Meeting. The EASD, one of the largest networks for diabetologists worldwide, holds its Annual Meeting in a different European city each year with more than 15,000 delegates from over 130 countries attending. This year’s 58th EASD Annual Meeting will be held in Stockholm, Sweden, 19 - 23 September 2022.
During the 2022 EASD annual meeting, Biomea’s abstract “Oral menin inhibitor, BMF-219, displays a significant and durable reduction in HbA1c in a type 2 diabetes rat model" has been accepted for Short Oral Discussion with presentation number 590 and “Oral long-acting menin inhibitor normalizes type 2 diabetes in two rat models” will be presented orally with presentation number 197. Both abstracts can be viewed as of today at www.easd.org.
Both presentations highlight BMF-219’s robust and prolonged glycemic control, insulin sensitization, and HbA1c reduction in two preclinical rat models of diabetes. These preclinical data support the potential utility of BMF-219 as a novel and acutely dosed oral, long-acting treatment for type 2 diabetes.
“We are honored to be selected for two oral presentations at the European Association for the Study of Diabetes Annual Meeting. The burden of diabetes remains unprecedented, with close to 10% of adults worldwide suffering from this disease and 1 in 3 Americans being prediabetic. Currently, diabetes typically requires daily treatment with multiple agents with various mechanisms of action in order to achieve glycemic control, however after several years they typically fail to maintain blood glucose control. The preclinical data that we have generated with oral BMF-219 to date and presented for the first time at the American Diabetes Association, may provide a true alternative as we are exploring to proliferate the beta cell mass and restore the body’s own ability to produce insulin, thereby reversing the downward spiral of type 2 diabetes,” said Thomas Butler, Biomea’s Chief Executive Officer, and Chairman of the Board. “In the STZ rat model, a model that displays a significant reduction in beta cell mass, and where non-insulin based therapies have been ineffective, BMF-219 is the first single agent treatment to show glycemic control after 14 days of treatment. A therapy that can generate glucose responsive beta cells would be a major break-through for patients with diabetes. We are excited about these results and look forward to submitting our IND in the second half of this year.”
Oral Presentation #197: (Thursday, September 22, 2022, 2:30 to 4:00 pm CEST) Oral Long-Acting Menin Inhibitor Normalizes Type 2 Diabetes in Two Rat Models Abstract Text:Background and aims: Menin is a scaffold protein that has been recognized for its role in T2DM as a key regulator of b-cell proliferation. Menin inhibition has previously been shown to improve glycemic control in diabetic mice. Herein, we report the first evidence that BMF-219, an orally bioavailable, selective, irreversible menin inhibitor, restores glycemic control in Zucker Diabetic Fatty (ZDF) Rat and Streptozotocin-induced (STZ) Rat models of T2DM.
Materials and methods: Rats were treated daily with BMF-219, vehicle, or pioglitazone for 16 days and analyzed for fasting and non-fasting blood glucose levels, insulin, c-peptide, and blood lipemic levels. Oral Glucose Tolerance Test (OGTT) was conducted up to Day 15 in both models and two-weeks post-treatment in the ZDF model. Body weight of all rats was also monitored.
Results: BMF-219 was well tolerated throughout the conduct of the study. BMF-219 treatment resulted in a significant 50% reduction in fasting and non-fasting blood glucose levels, reduced serum insulin and c-peptide levels (p