Proof of Concept clinical trial for Akaza Biosciences’ Resatorvid in Acute on Chronic Liver failure patients

Akaza Biosciences™ Resatorvid 在慢性肝衰竭患者急性治疗中的概念验证临床试验

• 批准号: 104474
• 金额: $ 340.41万
• 依托单位: AKAZA BIOSCIENCE
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2019
• 资助国家: 英国
• 起止时间: 2019 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=104474
• 关键词: Proof; Concept; clinical; trial; Akaza

Acute-on-chronic liver failure (ACLF) is a syndrome characterized by acute deterioration of existing chronic liver disease, progressing to organ failure and associated with a high mortality. It usually results after a precipitating event such as trauma, surgery, variceal bleeding, or infection that may directly exaggerate liver injury. There are no approved treatments for the condition. Management of ACLF focuses on rapid treatment of the precipitating event when this can be identified and the delivery of supportive care. The 28-day mortality in patients presenting with ACLF has been estimated to be approximately 34%. RESATORVID is a new first in class therapeutic approach with previous promising efficacy and safety in sepsis clinical trials. It has a unique way of working, and there is good evidence to suggest it will provide the first ever effective and targeted treatment for ACLF patients. Akaza Biosciences Ltd intend to progress Resatorvid into a Phase 2 clinical proof-of-concept trial in ACLF patients. Success would lead to an Orphan Drug Designation and eventual registration, and market availability in 2022\.

急性慢性上肝衰竭（ACLF）是一种以现有慢性肝病急性恶化、进展为器官衰竭并伴有高死亡率为特征的综合征。它通常发生在创伤、手术、静脉曲张出血或感染等可能直接加重肝损伤的突发事件之后。目前还没有批准的治疗方法。ACLF的管理侧重于快速治疗可识别的突发事件，并提供支持性护理。ACLF患者的28天死亡率估计约为34%。RESATORVID是一种新的一流治疗方法，先前在败血症临床试验中具有良好的疗效和安全性。它有一种独特的工作方式，有充分的证据表明，它将为ACLF患者提供有史以来第一个有效和有针对性的治疗。Akaza Biosciences Ltd打算将Resatorvid推进到ACLF患者的2期临床概念验证试验。成功将导致孤儿药指定和最终注册，并在2022年上市。