Background: Endogenous apoliloprotein E mediates neuroinflammatory responses and recovery after brain injury. Exogenously administered apolipoprotein E-mimetic peptides can effectively penetrate the brain and down-regulate acute inflammation. CN-105 is a novel apolipoprotein E-mimetic pentapeptide with excellent preclinical evidence as an acute intracerebral hemorrhage (ICH) therapeutic. The CN-105 in participants with Acute supraTentorial intraCerebral Hemorrhage (CATCH) trial is a first-in-disease-state, multi-center, open-label trial evaluating safety and feasability of CN-105 administration in patients with acute primary supratentorial ICH. Methods: Eligible patients were age 30-80 years, had confirmed primary supratentorial ICH, and able to intiate CN-105 administration (1.0 mg/kg every 6 hours for 72 hours) within 12 hours of symptom onset. A priori defined safety endpoints, including hematoma volume, pharmacokinetics, and 30-day neurological outcomes were analyzed. For comparisons, CATCH participants were matched 1:1 with a contemporary ICH cohort through random selection. Hematoma volumes determined from computed tomography images on Days 0, 1, 2, and 5 and ordinal modified Rankin Score at 30 days after ICH were compared. Results: In 39 participants enrolled across six study sites in the United States, adverse events occurred at expected rate without increase in hematoma expansion or neurological deterioration or significant serum accumulation. CN-105 treatment had an odds ratio (95% confidence interval) of 2.69 (1.31-5.51) for lower 30-day mRS, after adjustment for ICH Score, sex, and race/ethnicity, compared to matched contemporary cohort. Conclusion: CN-105 administration represents an excellent translational candidate as an actue ICH therapeutic due to its safety, dosing feasibility, favorable pharmacokinetics, and evidence of improved neurological recovery.

中文翻译：

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CN-105在参加急性腔上性颅内出血（CATCH）试验的参与者中

背景：内源性载脂蛋白E介导脑损伤后神经炎症反应和恢复。外源性载脂蛋白E-模拟肽可以有效渗透大脑并下调急性炎症。CN-105是一种新型的载脂蛋白E-模拟五肽，具有作为急性脑出血（ICH）治疗药物的优异的临床前证据。CN-105在急性腔上性脑内出血（CATCH）试验中的参与者是一项处于疾病初期状态，多中心，开放标签的试验，评估CN-105在急性原发性幕上性脑出血患者中的安全性和可行性。方法：符合条件的患者年龄为30-80岁，已确诊原发性幕上ICH，并能够在症状发作后的12小时内开始使用CN-105（每6小时服用1.0 mg / kg，持续72小时）。先验定义的安全性终点，包括血肿量，药代动力学和30天神经系统结果进行了分析。为了进行比较，通过随机选择使CATCH参与者与现代ICH队列1：1匹配。比较在ICH后30天时从第0、1、2和5天的计算机断层扫描图像确定的血肿体积和序贯修改的Rankin评分。结果：在美国六个研究地点招募的39名参与者中，不良事件以预期的速度发生，而血肿扩展或神经系统恶化没有增加，也没有明显的血清积聚。经过ICH得分，性别和种族/族裔校正后，与同期的同期队列比较，CN-105治疗的30天较低mRS的优势比（95％置信区间）为2.69（1.31-5.51）。结论：