BMF-219 is a novel investigational covalent menin inhibitor developed to regenerate insulin-producing beta cells with the aim to cure diabetes
Health Canada has cleared the initiation of COVALENT-112, a Phase II clinical trial of BMF-219 in adults living with type 1 diabetes (T1D), following FDA clearance of the initiation of COVALENT-112 in October 2023
The randomized, double-blind, placebo-controlled (n=150) trial in adults living with T1D will 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
The trial will also include an open label portion, enrolling participants in the US and Canada with T1D up to 15 years since diagnosis
REDWOOD CITY, Calif., Dec. 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 that Health Canada has cleared Biomea's Clinical Trial Application (CTA) to study BMF-219 in adults living with type 1 diabetes.
The objective of COVALENT-112 is to evaluate the safety, efficacy, and durability of BMF-219, a novel investigational covalent menin inhibitor, in potentially restoring beta cell function. Beta cell loss is a root cause of type 1 and type 2 diabetes. Menin inhibition has been demonstrated to restore 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.
COVALENT-112 trial (n=150) will 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 will also include an open label portion for adults with type 1 diabetes up to 15 years since diagnosis. The open label portion (n=40) will 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.
"Our study COVALENT-111 is currently enrolling persons with type 2 diabetes and has generated tremendous enthusiasm among investigators in Canada. We are now looking forward to examining the potential of BMF-219 in persons with type 1 diabetes with our study COVALENT-112 in this region. BMF-219 is designed to target a root cause of diabetes, a depleted pool of beta cells. Insulin-producing beta cells are necessary to establish glycemic control and are especially vital for people living with type 1 diabetes. We are very excited to explore BMF-219's potential not only in type 2 but now also in type 1 diabetes, to successfully restore the health and function of beta cells and re-establish the body's own mechanism to produce insulin naturally again," stated Juan Pablo Frias, MD, Biomea Fusion's Chief Medical Officer. He further added, "The newly added open label study is designed to enroll 40 adults living with type 1 diabetes at two different dose levels. We expect it will provide valuable insights early on to inform and apply learnings to the randomized blinded portion of the trial."
BMF-219 是一種新型的研究共價腦膜抑制劑，開發用於再生產生胰島素的 β 細胞，旨在治癒糖尿病
繼美國食品藥品管理局於 2023 年 10 月批准啓動 COVALENT-112 之後，加拿大衛生部已批准啓動 COVALENT-112，這是一項針對成人 1 型糖尿病 (T1D) 的 BMF-219 的二期臨床試驗
這項針對患有 T1D 的成年人的隨機、雙盲、安慰劑對照試驗（n=150）將檢查 BMF-219 在兩個口服劑量水平（100 mg 和 200 mg）下的安全性、有效性和耐久性，持續治療 12 周，然後是 40 周的非治療期
該試驗還將包括開放標籤部分，招收美國和加拿大的T1D參與者，自診斷起不超過15年
加利福尼亞州雷德伍德城，2023 年 12 月 5 日（GLOBE NEWSWIRE）——一家臨床階段的生物製藥公司 Biomea Fusion, Inc.（“Biomea”）（納斯達克股票代碼：BMEA）今天宣佈，加拿大衛生部已經批准了 Biomea 的臨床試驗申請 (CTA) 將在患有 1 型糖尿病的成年人中研究 BMF-219。
COVALENT-112 的目的是評估新型的研究共價腦膜抑制劑 BMF-219 在可能恢復 β 細胞功能方面的安全性、有效性和耐久性。β細胞流失是1型和2型糖尿病的根本原因。腦膜抑制已被證明可以恢復β細胞的功能。臨床前研究表明，BMF-219 有可能在 1 型和 2 型糖尿病的動物模型中特異性再生和保留產生胰島素的 β 細胞。
COVALENT-112 試驗（n=150）將在 3 年內以兩種口服劑量（100 mg 和 200 mg）在被診斷患有 1 型糖尿病的成年人中檢查 BMF-219 的安全性、有效性和耐久性，治療持續 12 周，然後停用 40 周。該試驗還將包括開放標籤部分，適用於自診斷起15年內患有1型糖尿病的成年人。開放標籤部分（n=40）將檢查 BMF-219 在兩個口服劑量水平下的安全性、有效性和耐久性，分別爲 100 mg 和 200 mg，持續了 12 周的治療期，然後是 40 周的非治療期。
“我們的研究 COVALENT-111 目前正在招收2型糖尿病患者，並引起了加拿大研究人員的極大熱情。我們現在期待通過我們在該地區的研究 COVALENT-112 來研究 BMF-219 在 1 型糖尿病患者中的潛力。BMF-219 旨在靶向糖尿病的根本原因，即耗盡的 β 細胞庫。產生胰島素的β細胞是控制血糖所必需的，對1型糖尿病患者尤其重要。Biomea Fusion首席醫學官胡安·巴勃羅·弗里亞斯醫學博士說，我們很高興能探索 BMF-219 在2型糖尿病中的潛力，以成功恢復β細胞的健康和功能，重建人體自身再次自然產生胰島素的機制。他進一步補充說：“新增的開放標籤研究旨在招收40名患有兩種不同劑量水平的1型糖尿病成年人。我們預計它將盡早提供寶貴的見解，爲試驗的隨機盲部分提供信息並應用所得經驗。”
