Alnylam Submits CTA Application for ALN-AGT, an Investigational RNAi Therapeutic for the Treatment of Hypertension in High Unmet Need Settings

生物技术公司 Alnyam 提交高血压 RNAi 疗法的 CTA 申请

2019-03-12 07:40:00 BioSpace

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Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, announced today that the Company has submitted a clinical trial authorization (CTA) application to The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom to initiate a Phase 1 study of ALN-AGT, an investigational RNAi therapeutic targeting angiotensinogen (AGT) for the treatment of hypertension in high unmet need populations, including patients with resistant or refractory hypertension, chronic kidney disease or heart failure. The Company plans to initiate a Phase 1 study in mid-2019, upon obtaining MHRA approval. “We are excited to expand our efforts in the cardiovascular disease setting in pursuit of a novel approach to treat hypertension, particularly given that hypertensive disorders are the leading preventable cause of death in modern society. With RNAi, we believe there’s an opportunity to reimagine the treatment of hypertension in high unmet need settings,” said Lauren Melton, Senior Director, Program Leader, ALN-AGT program at Alnylam. “We believe RNAi-mediated angiotensinogen silencing represents a novel approach with the potential to provide effective and highly durable control of blood pressure for patients with resistant or refractory hypertension, chronic kidney disease or heart failure. Pending feedback from the MHRA, we look forward to evaluating the safety and preliminary pharmacodynamic activity of this molecule in patients with hypertension.”
Alnyam Pharmaceuticals , Inc .( Nasdaq : ALNY ),领先的 RNAi 治疗公司今天宣布,公司已向英国药品和保健产品管理局( MHRA )提交临床试验授权申请,启动 ALN-AGT 的第一阶段研究,一种针对血管紧张素( AGT )的 RNAi 研究疗法,用于治疗高需求人群的高血压,包括有耐药或难治性高血压、慢性肾病或心脏衰竭的患者。公司计划在获得 MHRA 批准后,于2019年年中启动第一阶段研究。 “我们很高兴扩大我们在心血管疾病领域的努力,以寻求一种新的治疗高血压的方法,特别是考虑到高血压疾病是现代社会中主要的可预防的死亡原因。在 RNAi 的帮助下,我们相信有机会在未满足的高需求环境下重新开始治疗高血压,” Alnyam ALN-AGT 项目高级总监 LaurenMelton 说。“我们相信, RNAi 介导的血管紧张素沉默是一种新的方法,有可能为顽固性或顽固性高血压、慢性肾病或心脏衰竭患者提供有效和高度持久的血压控制。在等待 MHRA 的反馈之前,我们期待着评估这种分子在高血压患者中的安全性和初步药效活性。”

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