The FDA has cleared the initiation of COVALENT-112, a Phase II clinical trial of BMF-219 in adults with type 1 diabetes (T1D).The randomized, double-blind, placebo-controlled (N=150) trial in adults with T1D will examine the safety and efficacy of BMF-219 at two oral dose levels, 100 mg and 200 mg unfed, for 12-weeks of treatment followed by a 40 week off-treatment period.

美国食品和药物管理局已经批准了COVALENT-112的启动，这是BMF-219在成人1型糖尿病（T1D）中的II期临床试验。成人随机，双盲，安慰剂对照（N=150）T1D将检查BMF-219在两种口服剂量水平（100mg和200mg未进食）下治疗12周，然后是40周休息治疗期的安全性和有效性。

REDWOOD CITY, Calif., Oct. 05, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (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, today announced the U.S.

REDWOOD CITY，CA，2023年10月5日（GLOBE NEWSWIRE）-Biomea Fusion，Inc.（“Biomea”）（纳斯达克股票代码：BMEA），一家临床阶段的生物制药公司，致力于发现和开发新型共价小分子治疗和改善基因定义的癌症和代谢疾病患者的生活，今天美国宣布。

Food and Drug Administration (FDA) has cleared Biomea's IND application to study BMF-219 in adults with type 1 diabetes. The objective of COVALENT-112 is to evaluate the safety, efficacy, and durability of BMF-219, a covalent menin inhibitor, in potentially restoring beta cell function. Beta cell loss is a root cause of type 1 and type 2 diabetes.

美国食品和药物管理局（FDA）已批准Biomea的IND申请，以研究1型糖尿病成人的BMF-219。共价-112的目的是评估BMF-219（一种共价menin抑制剂）在潜在恢复β细胞功能中的安全性，有效性和耐久性。β细胞丢失是1型和2型糖尿病的根本原因。

Menin inhibition has been demonstrated to improve beta cell function. Preclinical studies have shown the potential of BMF-219 to specifically regenerate and retain insulin-producing beta cells in animal models of type 1 and type 2 diabetes. “We are excited to evaluate the potential impact BMF-219 may have in people with type 1 diabetes.

Menin抑制已被证明可改善β细胞功能。临床前研究显示BMF-219在1型和2型糖尿病动物模型中特异性再生和保留产生胰岛素的β细胞的潜力。“我们很高兴评估BMF-219对1型糖尿病患者的潜在影响。

Currently, the only available therapy for these patients is exogenous insulin which requires intensive management with chronic multiple daily insulin injections or treatment with an insulin pump, and has a risk of hypoglycemia, increased morbidity and mortality,” stated Juan Pablo Frias, MD, Biomea Fusion’s Chief Medical Officer.

目前，这些患者唯一可用的治疗方法是外源性胰岛素，需要长期多次每日注射胰岛素或用胰岛素泵治疗，并有低血糖，增加发病率和死亡率的风险，“Juan Pablo Frias医学博士说，Biomea Fusion的首席医疗官。

He added, “By targeting one of the root causes of diabetes,.

他补充说：“通过针对糖尿病的根本原因之一，。