REDWOOD CITY, Calif., June 06, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or the “Company”) (Nasdaq: BMEA), announced that the Company has received notice from the U.S. Food and Drug Administration (FDA) that a full clinical hold has been placed on Biomea’s ongoing Phase I/II clinical trials of the Company’s investigational covalent menin inhibitor BMF-219 in type 2 and type 1 diabetes (COVALENT-111 and COVALENT-112), respectively.

加利福尼亚州红木市，2024年6月6日（环球通讯社）--Biomea Fusion，Inc.（“Biomea”或“公司”）（纳斯达克：BMEA）宣布，该公司已收到美国食品和药物管理局（FDA）的通知，该公司正在进行的关于该公司研究性共价menin抑制剂BMF-219在2型和1型糖尿病（共价-111和共价-112）中的I/II期临床试验已被完全停止。

The Company will continue ongoing safety and efficacy data collection during the hold. “We respect the FDA’s decision and agree that patient safety is paramount and our top priority. We are fully collaborating and working diligently with the FDA to put a plan in place as quickly as possible to ensure patient safety and look forward to resuming the studies once we have authorization from the FDA.

该公司将在停工期间继续进行持续的安全性和有效性数据收集。“我们尊重FDA的决定，并同意患者安全是最重要的，也是我们的首要任务。我们正在与FDA充分合作并努力工作，以尽快制定计划，确保患者安全，并期待在获得FDA授权后恢复研究。

The results to date have supported that BMF-219 is generally well-tolerated and can restore glucose-controlled insulin production and improve glycemic control. Based on the totality of the safety and efficacy data for BMF-219 in diabetes to date, we remain committed to advancing BMF-219 with its potentially transformative profile,” stated Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board.

迄今为止的结果支持BMF-219通常具有良好的耐受性，可以恢复葡萄糖控制的胰岛素产生并改善血糖控制。基于迄今为止BMF-219在糖尿病中的安全性和有效性数据，我们仍然致力于推进BMF-219及其潜在的变革性特征，”Biomea Fusion首席执行官兼董事会主席托马斯·巴特勒（Thomas Butler）表示。

The FDA cited deficiencies based on the level of possible drug-induced hepatotoxicity observed in the completed Dose Escalation Phase of COVALENT-111. During the Dose Escalation studies, higher doses (up to 400 mg), various food intake regimens, medical history and concomitant medications may have contributed to observed liver enzyme elevations.

FDA根据在共价-111的完成剂量递增阶段观察到的可能的药物诱导的肝毒性水平引用了缺陷。在剂量递增研究期间，较高剂量（高达400 mg），各种食物摄入方案，病史和伴随药物可能导致观察到的肝酶升高。

As previously reported, the majority of adverse events (AEs) have been mild to moderate in nature and no serious adverse reactions (SARs) have been reported to date with BMF-219 in.

如先前报道，大多数不良事件（AE）性质为轻度至中度，迄今为止，BMF-219尚未报告严重不良反应（SARs）。