NeuroVive’s NeuroSTAT Project receives FDA fast track designation


2019-07-30 12:01:00 PHARMACEUTICAL


NeuroSTAT’s FDA Fast Track designation makes NeuroVive eligible, for example, for more frequent meetings and written communication with the FDA, continuous feedback on each section of its New Drug Application, NDA , as well as the possibility to have its NDA reviewed within a shorter timeframe. Fast Track designated drugs address unmet medical needs in serious conditions, and the process is designed to facilitate accelerated drug development and, ultimately, to get new drugs to patients faster. NeuroSTAT protects and stabilizes mitochondria and is in development for treatment of moderate to severe traumatic brain injury. It focuses on secondary brain cell damage that occurs after a head trauma. The candidate drug has previously been evaluated in a European clinical Phase II trial focused on safety, where analyses of brain cell injury biomarkers showed signals of clinical effect. In addition, in a clinically relevant experimental model, NeuroSTAT significantly reduced the volume of brain injury by 35%. NeuroSTAT has orphan drug designation in both Europe and the US. “The Fast Track designation and the recently approved IND (Investigational New Drug) are tremendous successes for our candidate drug NeuroSTAT, and a significant external validation of its quality and potential to address a tremendous unmet medical need. This will strengthen our position in the field and give us an advantage in partnering discussions concerning our planned Phase II efficacy study”, said NeuroVive’s CEO Erik Kinnman.
NeuroSTAT 的 FDA 快速跟踪指定使 NeuroVive 有资格,例如,更频繁的会议和与 FDA 的书面沟通,对其新药申请的每一部分的持续反馈,以及在更短的时间内审查其 NDA 的可能性。快速跟踪指定药品在严重情况下满足未得到满足的医疗需求,该过程旨在促进加快药物开发,并最终加快向患者获取新药的速度。 神经 STAT 保护和稳定线粒体,并正在发展为治疗中至重度创伤性脑损伤。它集中于脑损伤后发生的继发性脑细胞损伤。候选药物此前已在欧洲临床 II 期试验中进行了安全性评价,其中对脑细胞损伤生物标志物的分析显示出临床疗效的信号。此外,在临床相关的实验模型中, NeuroSTAT 显著减少了35%的脑损伤体积。NeuroSTAT 在欧洲和美国都有孤儿药物的指定。 “快速通道的指定和最近批准的 IND (调查新药)对我们的候选药物 NeuroSTAT 来说是巨大的成功,对其质量和潜力进行了重大的外部验证,以满足巨大的未满足的医疗需求。NeuroVive 首席执行官 Erik Kinnman 表示:“这将加强我们在该领域的地位,并使我们在有关我们计划开展的 II 期疗效研究的讨论中拥有优势。”