PANGYO, South Korea, Feb. 23, 2024 /PRNewswire/ -- Oscotec Inc. and ADEL Inc. announced the dosing of the first healthy participant in its first-in-human study of ADEL-Y01 for the treatment of Alzheimer's disease (AD).

韩国PANGYO，2024年2月23日/PRNewswire/--Oscotec Inc.和ADEL Inc.宣布，在其首次用于治疗阿尔茨海默病（AD）的ADEL-Y01人体研究中，第一位健康参与者的剂量。

Oscotec and ADEL are jointly developing a novel disease-modifying immunotherapy agent (ADEL-Y01) targeting tau protein accumulation in the AD brain. ADEL-Y01 is uniquely designed to target tau protein acetylated at lysine-280 (acK280), inhibiting aggregation and propagation of toxic tau and thus may slow the course of the disease..

Oscotec和ADEL正在联合开发一种针对AD大脑中tau蛋白积累的新型疾病修饰免疫治疗剂（ADEL-Y01）。ADEL-Y01被独特设计用于靶向赖氨酸280（acK280）乙酰化的tau蛋白，抑制有毒tau的聚集和繁殖，从而可能减缓疾病进程。。

This phase 1a/1b study in the U.S. is to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of ADEL-Y01 in 40 healthy volunteers as well as in 33 participants with Mild Cognitive Impairment due to Alzheimer's disease or mild Alzheimer's disease.

美国的这项1a/1b期研究旨在评估ADEL-Y01在40名健康志愿者以及33名因阿尔茨海默氏病或轻度阿尔茨海默氏病导致轻度认知障碍的参与者中的安全性，耐受性，药代动力学和临床活性。

'Given that tau is strongly correlated with AD progression and clinical severity, targeting of tau is anticipated to effectively slow the disease progress. As our understanding of the pivotal role of the tau mid-region MTBR increases, selecting the right epitope becomes crucial in developing tau-targeting therapeutics to attain clinical benefits', explained SeungYong Yoon, MD/PhD, CEO of ADEL..

“鉴于tau与AD进展和临床严重程度密切相关，预计tau的靶向可有效减缓疾病进展。随着我们对tau中区MTBR关键作用的理解增加，选择正确的表位对于开发tau靶向治疗以获得临床益处至关重要”，ADEL首席执行官SeungYong Yoon博士解释道。。

'Oscotec is pleased to reach a significant milestone leading the clinical study as a co-developer with ADEL, and we will continue to bring innovative medicines in neurogenerative diseases', said Taeyoung Yoon, CEO of Oscotec.

Oscotec首席执行官Taeyoung Yoon说：“Oscotec很高兴与ADEL共同开发临床研究，取得了一个重要的里程碑，我们将继续为神经生成性疾病带来创新药物。”。

The preclinical results of ADEL-Y01 in animal models were published last year, demonstrating improvement in  memory impairment, behavioral deficits through the inhibition of Tau seeding and propagation.('Monoclonal antibody Y01 prevents tauopathy progression induced by lysine 280–acetylated tau in cell and mouse models' in The Journal of Clinical Investigation 2023).

ADEL-Y01在动物模型中的临床前结果于去年发表，通过抑制Tau播种和繁殖，证明了记忆障碍，行为缺陷的改善。（《临床研究杂志2023》中的“单克隆抗体Y01可预防赖氨酸280-乙酰化tau在细胞和小鼠模型中诱导的tau蛋白病进展”。

About Oscotec Inc.Oscotec is a clinical stage drug discovery and development company pursuing translation of  rigorous science into innovative medicine for clinically unmet needs.. The Company's clinical pipeline consists of targeted therapeutics in immunology and oncology. Oscotec is developing cevidoplenib (SYK inhibitor) for ITP (Phase 2, completed) and FLT3/AXL inhibitor for AML (Phase 1) as well as solid tumors (Phase 1).

关于Oscotec Inc.Oscotec是一家临床阶段药物发现和开发公司，致力于将严谨的科学转化为创新医学，以满足临床未满足的需求。。该公司的临床渠道包括免疫学和肿瘤学的靶向治疗。Oscotec正在开发用于ITP（第2阶段，已完成）的cevidoplenib（SYK抑制剂）和用于AML（第1阶段）以及实体瘤（第1阶段）的FLT3/AXL抑制剂。

The company is also the originator of Lazertinib (LECLAZA®), a 3rd generation EGFR inhibitor being developed by Janssen Pharma and Yuhan Corp. for lung cancers..

该公司也是Lazertinib（LECLAZA®）的创始人，Lazertinib是Janssen Pharma和Yuhan Corp.为肺癌开发的第三代EGFR抑制剂。。

About ADEL Inc.ADEL is a leading company of cutting-edge technologies for the treatment and diagnosis of neurological diseases including Alzheimer's disease. Founded by scientists who have investigated Alzheimer's disease at Asan Medical Center, University of Ulsan College of Medicine, Korea, ADEL is developing smart, innovative drug candidates for the patients worldwide..

关于ADEL Inc.ADEL是一家领先的尖端技术公司，用于治疗和诊断包括阿尔茨海默氏病在内的神经系统疾病。ADEL由在韩国蔚山大学医学院Asan医学中心研究阿尔茨海默氏病的科学家创立，目前正在为全球患者开发智能、创新的候选药物。。

Contacts

联系人

Jihyun Park, IR/PR[email protected]

Jihyun Park，IR/PR[电子邮件保护]

Kyung Hoon Hwang, Research Director/COO[email protected]

Kyung Hoon Hwang，研究总监/首席运营官[电子邮件保护]

SOURCE Oscotec Inc.

SOURCE Oscotec Inc.