SNP318, a novel, small molecule, orally administered, brain penetrant lipoprotein-associated phospholipase A2 (Lp-PLA2) inhibitor, was well-tolerated in the Phase 1 study.

SNP318是一种新型的小分子口服脑渗透脂蛋白相关磷脂酶A2（Lp-PLA2）抑制剂，在1期研究中耐受性良好。

Inhibition of Lp-PLA2 improves integrity of blood-brain barrier (BBB), that has previously resulted in clinical benefit in Alzheimer's disease (AD)1.

Lp-PLA2的抑制改善了血脑屏障（BBB）的完整性，这以前导致阿尔茨海默病（AD）1的临床益处。

SNP318 Phase 2 study is planned for 2024.

SNP318第二阶段研究计划于2024年进行。

ROCKVILLE, Md., Nov. 30, 2023 /PRNewswire/ -- SciNeuro Pharmaceuticals, a clinical stage biotech company focused on developing treatments for neurodegenerative diseases, particularly Alzheimer's Disease (AD) and Parkinson's Disease (PD), today announced the completion of dosing in its Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study.

ROCKVILLE，Md.，2023年11月30日/PRNewswire/-SciNeuro Pharmaceuticals，一家临床阶段生物技术公司，专注于开发神经退行性疾病，特别是阿尔茨海默病（AD）和帕金森病（PD）的治疗方法，今天宣布完成给药在其第1阶段，随机，双盲，安慰剂对照，单次和多次递增剂量研究中。

The trial was designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the company's lead clinical asset, SNP318, in healthy participants. Administration of SNP318 was well-tolerated with a favorable exposure, strong target engagement, and excellent safety profile. Additionally, the CNS penetrance and food effects were investigated separately.

该试验旨在评估该公司主要临床资产SNP318在健康参与者中的安全性，耐受性，药代动力学和药效学。SNP318的给药耐受性良好，暴露良好，目标参与度强，安全性好。此外，分别研究了中枢神经系统的渗透率和食物效果。

These results support further development with once daily dosing. A Phase 2 study to assess clinical benefits of SNP318 in stratified AD patients is planned for 2024 as the next step to continue its global development..

这些结果支持每日一次给药的进一步发展。计划于2024年进行一项评估SNP318在分层AD患者中的临床益处的2期研究，作为继续其全球发展的下一步。。

'We are delighted to see the scheduled conclusion and informative outcomes of a well planned and executed SNP318 Phase 1 study, thanks to the SciNeuro clinical and translation teams,' said Min Li, Ph.D., founder and CEO of SciNeuro Pharmaceuticals. 'These results represent a significant step forward in our efforts to further clinical development of SNP318.

“由于SciNeuro临床和翻译团队的支持，我们很高兴看到一项精心策划和执行的SNP318第一阶段研究的预定结论和信息成果，”SciNeuro制药公司创始人兼首席执行官李敏博士说这些结果代表了我们努力进一步开展SNP318临床开发的重要一步。

Our very special gratitude also extends to all the trial participants and dedicated clinical team in Australia. We look forward to continuing our work by addressing neurovascular deficits common among AD to improve the patients' lives affected by these devastating conditions.'.

我们非常感谢澳大利亚的所有试验参与者和专门的临床团队。我们期待通过解决AD中常见的神经血管缺陷来继续我们的工作，以改善受这些破坏性疾病影响的患者生活。

Topline Phase 1 study data summary

Topline阶段1研究数据摘要

SNP318 was safe and well-tolerated with no serious adverse events (SAEs) observed.

SNP318安全且耐受性良好，未观察到严重不良事件（SAE）。

Pharmacokinetics and pharmacodynamics data revealed excellent oral exposure supporting for once-daily dosing.

药代动力学和药效学数据显示优异的口服暴露支持每日一次给药。

SNP318 has outstanding distribution in the cerebrospinal fluid (CSF) to achieve complete target inhibition in a clinical setting for both peripheral and CNS tissues.

SNP318在脑脊液（CSF）中具有突出的分布，以在外周和CNS组织的临床环境中实现完全的靶标抑制。

AD and Vascular Pathology

AD和血管病理学

More than 80% AD patients exhibit vascular pathology, a key driver of cognitive decline. While etiology is heterogenous, vascular lesion alone suffices to cause dementia commonly known as vascular dementia. Vascular dementia and AD have considerable overlap. Studying Late-Onset Alzheimer's Disease (LOAD) by following both patients and healthy subjects indicated intra-brain vascular dysfunction is an early and predominant disease development event preceding or independent of amyloid pathology..

超过80%的AD患者表现出血管病变，这是认知能力下降的关键驱动因素。虽然病因是异质性的，但单独的血管病变足以引起通常称为血管性痴呆的痴呆。血管性痴呆和AD有相当大的重叠。通过跟踪患者和健康受试者研究迟发性阿尔茨海默病（LOAD）表明，脑内血管功能障碍是淀粉样蛋白病理学之前或独立于淀粉样蛋白病理学的早期和主要疾病发展事件。。

About Lp-PLA2

关于Lp-PLA2

Lp-PLA2 is a phospholipase secreted primarily by inflammatory cells, including peripheral and CNS cells. Lp-PLA2 hydrolyzes oxidized phospholipids, producing lysophosphatidylcholine (LysoPC) and other potent proinflammatory factors. LysoPC is a key mediator of inflammatory stress on brain microvascular endothelial cells resulting in vascular pathology including vessel leakage and other BBB damage..

Lp-PLA2是主要由炎性细胞分泌的磷脂酶，包括外周和CNS细胞。Lp-PLA2水解氧化磷脂，产生溶血磷脂酰胆碱（LysoPC）和其他有效的促炎因子。LysoPC是脑微血管内皮细胞炎症应激的关键介质，导致血管病变，包括血管渗漏和其他BBB损伤。。

About SNP318

关于SNP318

SNP318 is a potent Lp-PLA2 inhibitor that dampens vascular inflammation, a common pathological feature of multiple neurodegenerative diseases. SNP318 is the only CNS-penetrant Lp-PLA2 inhibitor in clinical development that has been specifically optimized for the treatment of CNS disorders. Therefore, SNP318, independent from anti-amyloid strategy, has the potential to become a new AD therapy..

SNP318是一种有效的Lp-PLA2抑制剂，可抑制血管炎症，血管炎症是多种神经退行性疾病的常见病理特征。SNP318是临床开发中唯一针对CNS疾病治疗进行了专门优化的CNS渗透性Lp-PLA2抑制剂。因此，SNP318独立于抗淀粉样蛋白策略，有可能成为一种新的AD疗法。。

About SciNeuro Pharmaceuticals

关于SciNeuro制药

SciNeuro Pharmaceuticals is a clinical-stage biotechnology company focused on developing groundbreaking therapies for neurodegenerative diseases. Since its founding in 2020, SciNeuro has built a portfolio of pipeline programs staged from discovery to clinical development by addressing three key disease-driving mechanisms of neurodegeneration – neurovascular inflammation, proteinopathy, and immune response.

SciNeuro Pharmaceuticals是一家临床阶段生物技术公司，专注于开发神经退行性疾病的开创性疗法。自2020年成立以来，SciNeuro通过解决神经退行性疾病的三个关键疾病驱动机制-神经血管炎症，蛋白病和免疫反应，建立了从发现到临床开发阶段的管道计划组合。

The company aims to develop disease-modifying treatment options for Alzheimer's disease, Parkinson's disease, and other devastating CNS diseases. For more information, please visit www.scineuro.com..

该公司旨在为阿尔茨海默病，帕金森病和其他破坏性中枢神经系统疾病开发疾病改善治疗方案。欲了解更多信息，请访问www.scineuro.com。。

Reference:

参考：

Maher-Edwards G, De'Ath J, Barnett C, Lavrov A, Lockhart A. A 24-week study to evaluate the effect of rilapladib on cognition and cerebrospinal fluid biomarkers of Alzheimer's disease. Alzheimers Dement (N Y). 2015 Jun 30;1(2):131-140. doi: 10.1016/j.trci.2015.06.003. PMID: 29854933; PMCID: PMC5975052..

Maher-Edwards G，De'Ath J，Barnett C，Lavrov A，Lockhart A.一项为期24周的研究，旨在评估利拉帕迪对阿尔茨海默病认知和脑脊液生物标志物的影响。阿尔茨海默氏症（N Y）。2015年6月30日；1（2）：131-140。doi:10.1016/j.trci.2015.06.003。结论：29854933；PMCID:PMC5975052。。

SciNeuro Media ContactJessie Yang[email protected]

SciNeuro Media Contact Jessie Yang[电子邮件保护]

SOURCE SciNeuro Pharmaceuticals

来源SciNeuro制药