Loss of functional Beta-cell mass is a core component of the natural history in both types of diabetes — type 1 diabetes (mediated by autoimmune dysfunction) and type 2 diabetes (mediated by metabolic dysfunction). Beta-cells are found in the pancreas and are responsible for the synthesis and secretion of insulin. Insulin is a hormone that helps the body use glucose for energy and helps control blood glucose levels. In patients with diabetes, Beta-cell mass and function are diminished, leading to insufficient insulin secretion and hyperglycemia. Menin is thought to act as a brake on Beta-cell turnover / Beta-cell growth, supporting the notion that inhibition of menin could lead to the regeneration of normal healthy Beta-cells. Notably, it has previously been shown that knocking out the gene responsible for the creation of menin (MEN1) has been observed to produce profound glycemic control in diabetic animal models. Based on these and other scientific findings, Biomea explored the potential for menin inhibition as a viable therapeutic approach to permanently halt or reverse progression of type 2 diabetes.
Focusing on the hallmark of type 2 diabetes, Beta-cell dysfunction and loss of Beta-cell mass, Biomea conducted both the ZDF and the STZ experiments to measure the potential impact of BMF-219 for the treatment of type 2 diabetes. In both models, BMF-219 was able to normalize glucose levels in the majority of animals after just two weeks of treatment. Notably, the majority of the effect was maintained despite complete washout of BMF-219. Together, Biomea believes these results indicate the clinical potential for a novel menin inhibitor as a ground-breaking treatment for type 2 diabetes. Detailed reviews of both studies will be submitted to an upcoming scientific conference. The company intends to hold a meeting with regulators this quarter to discuss plans for a Phase 1/2 study.
“While the importance of menin in Beta-cell biology has been studied for some time, the normalization of insulin and glucose levels and potential repopulation of Beta-cells with a menin inhibitor in two distinct models is very unusual and noteworthy,” said
“We are a patient focused organization and we ‘aim to cure.’ As we reviewed the literature originally, we saw the relevance of menin in metabolic diseases and were compelled to explore the potential of our irreversible menin inhibitor for the benefit of patients,” said
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Statements we make in this press release may include statements which are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact, including statements regarding the clinical and therapeutic potential of our product candidates and development programs, including BMF-219, the potential of BMF-219 as a treatment for diabetes, our research, development and regulatory plans, including our plans to discuss with regulators the potential clinical development of BMF-219 and our plans to file an IND and initiate clinical trials, and the timing of such events, may be deemed to be forward-looking statements. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions.
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