Diabetes is an increasing cause of atherosclerotic and cardiovascular illnesses in South Korea. The clinical application of ultrasound for measuring carotid intima-media thickness, which helps in early detection and surveillance of atherosclerosis, is advancing. Due to lifestyle changes and an aging population, Koreans, especially diabetics, are developing more vascular diseases and are at higher risk for peripheral vascular disorders. Diabetics with lower limb peripheral artery disease require effective therapy to avoid major complications and a reduced quality of life. Although licensed for symptom control, Clopidogrel and Cilostazol have not yet been established for primary prevention of cardiovascular risks. These medications will be evaluated for their potential as primary preventive agents against cardiovascular disease in type 2 diabetes patients. The goal of this research is to investigate the efficacy of Cilostazol and Clopidogrel in inhibiting the progression of carotid atherosclerosis and to evaluate their influence on hemorheological changes in individuals with Type 2 diabetes. The goal of this research is to investigate the efficacy of Cilostazol and Clopidogrel in inhibiting the progression of carotid atherosclerosis and evaluating their influence on alterations in blood flow among individuals with Type 2 diabetes.

开始日期2024-04-16

申办/合作机构

Seoul National University Bundang Hospital

[+1]

NCT05995600 / Recruiting临床4期IIT

Comparison of Clopidogrel-based Antiplatelet Therapy Versus Warfarin As Secondary Prevention Strategy for AntiPhospholipid Syndrome-related STROKE (APS-STROKE)

Antiphospholipid syndrome (APS) has a close association with ischemic stroke; however, the optimal treatment strategy for APS-related stroke has yet to be established. The clinical guidelines suggest using warfarin for APS-related stroke, but these suggestions are largely based on retrospective studies from the 1990s and expert opinion, rather than high-quality clinical trials. Moreover, the evidence on the role of antiplatelet drugs other than aspirin (e.g., clopidogrel) in APS-related stroke is particularly limited. Considering the relatively young age of patients with APS and the high clinical burden of using warfarin, it is necessary to verify whether warfarin is essential. Thus, the investigators aim to compare clopidogrel-based antiplatelet therapy and warfarin as a secondary preventive medication for patients with APS-related stroke. APS-STROKE is an exploratory, multicenter, prospective, randomized, open, blinded-endpoint clinical trial. Adult patients with definite APS who have a history of ischemic stroke will be included. Patients with high-risk APS (triple positivity or persistently high titers of anti-cardiolipin or anti-β2-glycoprotein I antibodies), systemic lupus erythematous, or indications for continued antiplatelet or anticoagulant therapy will be excluded. Eligible patients will be 1:1 randomized to receive clopidogrel-based antiplatelet therapy or warfarin. Patients assigned to the clopidogrel-based antiplatelet therapy group will be permitted to use additional antiplatelet drugs other than clopidogrel at the investigator's discretion. The primary outcome is a composite of any death, major adverse cardiovascular events, systemic thromboembolic events, and major bleeding during a follow-up period of at least 4 years. This study would provide valuable information for determining the optimal secondary prevention strategy for APS-related stroke.

开始日期2024-02-20

申办/合作机构

Seoul National University Hospital

[+1]

NCT06216769 / RecruitingN/AIIT

Comparison Between Continuous Oral Anticoagulation Versus Pill-in-the-POCKET Oral AntiCoagulation Strategy Guided by Continuous Rhythm Monitoring Using Implantable Loop Recorder After Atrial Fibrillation Catheter Ablation

The clinical benefit of pill-in-the-POCKET anticoagulation after atrial fibrillation catheter ablation remains uncertain. We aimed to evaluate the clinical benefit and safety of pill-in-the-POCKET anticoagulation after atrial fibrillation catheter ablation by randomizing into two groups: non-interrupted anticoagulation after the procedure and anticoagulation based on atrial fibrillation recurrence confirmed by implantable loop recorders.

开始日期2024-02-01

申办/合作机构

Seoul National University Hospital

[+2]

100 项与 Samjin Pharmaceutical Co., Ltd. 相关的临床结果

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0 项与 Samjin Pharmaceutical Co., Ltd. 相关的专利（医药）

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项与 Samjin Pharmaceutical Co., Ltd. 相关的文献（医药）

2018-05-01·Journal of microbiology (Seoul, Korea)

Erratum to: A murine colitis model developed using a combination of dextran sulfate sodium and Citrobacter rodentium

作者: Park, Jong-Hyung ; Ryu, Seung-Hyun ; Choi, Yang-Kyu ; Park, Jin-Il ; Seo, Sun-Min ; Jeon, Hee-Yeon ; Kim, Jun-Young

In the article by Park et al. published in Journal of Microbiology 2018; 56, 272-279, the supplementary data Figs S1 and S2 should be corrected as below. The original article can be found online at https://doi.org/10.1007/s12275-018-7504-x .

2008-01-01·Antimicrobial agents and chemotherapy2区 · 医学

Comparative Evaluation of the Inhibitory Activities of a Series of Pyrimidinedione Congeners That Inhibit Human Immunodeficiency Virus Types 1 and 2

2区 · 医学

Article

作者: Watson, Karen M. ; Buckheit, Robert W. ; Chung, Sun-Gan ; Cho, Eui-Hwan ; Hartman, Tracy L.

ABSTRACT:

Seventy-three analogs of SJ-3366 (1-(3-cyclopenten-1-ylmethyl)-5-ethyl-6-(3,5-dimethylbenzoyl)-2,4(1H,3H)-pyrimidinedione) were synthesized and comparatively evaluated for their ability to inhibit the replication of human immunodeficiency virus type 1 (HIV-1) and HIV-2 and for their ability to suppress virus entry and reverse transcription. These studies were performed to identify inhibitors with activity greater than that of the current lead molecule (SJ-3366) and to utilize structure-activity relationships (SAR) to define the chemical features of the pyrimidinedione congeners responsible for their efficacy, toxicity, and dual mechanism of action against HIV. The results of our SAR evaluations have demonstrated that the addition of the homocyclic moiety at the N-1 of the pyrimidinedione results in acquisition of the ability to inhibit virus entry and extends the range of action of the compounds to include HIV-2. In addition, the results demonstrate that analogs with a methyl linker between the homocyclic substitution and the N-1 of the pyrimidinedione had a greater number of highly active molecules than those analogs possessing ethyl linkers. Six molecules were identified with activity equivalent to or greater than that of SJ-3366, and five additional molecules with highly potent inhibition of reverse transcriptase and virus entry and possessing high efficacy against both HIV-1 and HIV-2 were identified. Six molecules exhibited significant inhibition of viruses with the highly problematic nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance engendering amino acid change K103N in the reverse transcriptase. These evaluations indicate that a new class of NNRTIs has been identified and that these NNRTIs possess highly potent inhibition of HIV-1 with an extended range of action, which now includes HIV-2.

2007-10-01·Antiviral chemistry & chemotherapy

The Structure-Activity Relationships of 2,4(1H,3H)-pyrimidinedione Derivatives as potent HIV type 1 and type 2 inhibitors

Article

作者: Kwon, Ho Seok ; Buckheit, Robert W ; Cho, Eui Hwan ; Watson, Karen M ; Hartman, Tracy L ; Chung, Sun Gan ; Kang, Dong Wook ; Lee, Sun Hwan ; Lee, Jae Woong

Since the discovery of the 2,4 (1 H,3 H)-pyrimidinediones as potent non-nucleoside inhibitors of the HIV-1 reverse transcriptase (RT) this class of compounds has yielded a number of N-1 acyclic substituted pyrimidinediones with substantial antiviral activity, which is highly dependent upon their molecular fit into the binding pocket common to this inhibitory class. We have specifically examined the structure activity relationships of compounds with chemical modification made by substituting homocyclic rather than acyclic moieties at N-1 of the pyrimidinedione. Seventy-four compounds were synthesized and evaluated for antiviral activity against HIV-1 and HIV-2. The homocyclic modifications resulted in compounds with significant activity against both HIV-1 and HIV-2, suggesting these compounds represent a new class of non-nucleoside RT inhibitors. The structure-activity relationship (SAR) evaluations indicated that cyclopropyl, phenyl and 1- or 3-cyclopenten-1-yl substitutions at the N-1 of the pyrimidinedione, the addition of a methyl linker between the cyclic moiety and the N-1 and the addition of a benzoyl group at the C-6 of the pyrimidinedione had the greatest contribution to antiviral activity. Five pyrimidinedione analogues with therapeutic indexes (TIs)>450,000 and a specific analogue (1-cyclopropylmethyl-5-isopropyl-6-(3,5-dimethylbenzoyl)-2,4(1 H,3 H)-pyrimidinedione), which exhibited a TI of >2,000,000, were identified. None of the analogues were cytotoxic to target cells at the highest in vitro test concentration, which is the upper limit of compound solubility of the analogues in aqueous solution. Thus, we have identified a series of pyrimidinediones with substantially improved antiviral efficacy and range of action and with significantly reduced cellular cytotoxicity.

项与 Samjin Pharmaceutical Co., Ltd. 相关的新闻（医药）

2024-04-29

·药研网

AriBio: PDE-5抑制剂AR1001治疗AD III期临床试验获欧洲EMA批准

据外媒Business Wire报道，4月29日，AriBio的PDE5抑制剂AR1001治疗AD III期临床试验POLARIS-AD获得欧洲药品管理局（EMA）授权。EMA成为继美国FDA和英国MHRA后，又一授权POLARIS-AD正式开展临床试验的监管机构。AR1001是一种靶向磷酸二酯酶-5（PDE-5）的小分子抑制剂，具有治疗阿尔茨海默病的新型多药理学机制。在临床前研究中，AR1001被证明可通过抑制神经元凋亡和恢复突触可塑性而发挥神经保护作用，证明了可能改善AD病程的疾病调节作用的多种作用机制。此外，AR1001还显示出对淀粉样斑块和tau蛋白的积极作用。Pipeline of AriBio目前，AriBio已经完成了一项AR1001治疗轻至中度AD患者的2期研究。AD患者在接受治疗52周后，与基线相比，阿尔茨海默病合作试验-临床整体印象变化（ADCS-CGIC）评分分别下降了1.17分（10 mg组）和0.76分（30 mg组）。对于仅接受AR1001的轻度AD患者，10 mg组成员显示出2.4分（15.1%）的评分改善，30 mg组成员在52周时比基线改善了8.7分（46.3%，P=0.001）。在确认AR1001对轻度AD患者的治疗益处后，AriBio公司正在早期AD人群中进行3期临床研究。AR1001-ADP3-US01（POLARIS-AD，NCT05531526）是一项3期双盲、随机、安慰剂对照、多中心试验，评估AR1001对早期阿尔茨海默病患者的疗效和安全性。该试验使用了美国食品药品监督管理局和欧洲药品管理局认可的主要终点，临床痴呆评定总和量表（CDR-SB），以及次要终点，包括阿尔茨海默病评估量表-认知亚量表13（ADAS-Cog 13）、阿姆斯特丹日常生活功能活动问卷（A-iADL）、老年抑郁症量表（GDS）、简易心智功能评估（MMSE），以及脑脊髓液（CSF）和血浆生物标志物的变化。AR1001临床研发计划获EMA批准是继美国、英国和韩国批准后的又一个里程碑。目前，预计1150名受试者将被收录在到此3期临床试验中，横跨全球200个受试点。今年3月，AriBio宣布以总额高达7.7亿美元（约55.9亿元人民币）的价格签署了治疗早期AD的研究药物AR1001在中国的独家营销权的授权协议（被许可方未披露）。此前，AriBio已与Samjin Pharmaceutical合作，向其授予了1000亿韩元的韩国独家销售权。“皇冠上的明珠”目前，全球约有5000万人罹患阿尔兹海默症，预计到2050年，增加至1.52亿人。鉴于阿尔茨海默病有着庞大的市场需求，被药物研发界视作“皇冠上的明珠”。当前，全球每年用于治疗、护理阿尔兹海默症病人的费用已经达到1万亿美元，而这一数字将在2030年达到目前的两倍，可见阿尔兹海默症药物将具有广阔的市场。许多知名制药公司都在寻求开发安全有效的阿尔茨海默病口服治疗药物。然而过去20年中，阿尔茨海默病（AD）药物研发面临巨大挑战，药物的失败率高达99%！从1993年到2023年，在阿尔茨海默病治疗药物领域内，FDA共批准了7种药物，涵盖了不同的作用机制和药物类型。第一款被获得FDA批准的新一代阿兹海默特效药，是卫材的Lecanemab（仑卡奈单抗），也是目前全球唯一一款完全获批的通过清除Aβ来延缓AD进展、降低认知功能衰退速度的药物，2023年7月获FDA完全批准。（aducanumab的2021年批准为附条件批准）迄今，进展最快的应属卫材与礼来制药合作开发的单克隆抗体donanema，目前正处于III期试验。但今年3月8日，FDA宣布推迟礼来donanemab药物的上市批准，并将组织外部专家会议讨论该药物的安全性和有效性。据悉，这是该药物第二次遭遇监管审批延期。FDA将此次延期推迟到2024年第一季度之后。在国内医药领域，据药物临床试验登记与信息公示平台数据，全国共有阿尔茨海默病药物相关临床试验91项。截至目前，国内布局该病的新药研发上市公司包括先声药业、恒瑞医药、通化金马等。恒瑞医药自主研发的Aβ单抗处于临床2期的研究阶段，2023年3月完成了首例患者入组及给药；先声药业则采取仿创结合的策略，与Vivoryon达成超5亿美元的合作，成功引进口服QPCT小分子抑制剂进入临床II期试验；2023年9月，通化金马宣布旗下1.1类新药琥珀八氢氨吖啶片用于治疗轻、中度AD的III期临床试验已完成揭盲和主要数据的统计分析，达到主要终点。药物之外，无创脑刺激、干细胞疗法等临床试验也在加快进行中。尽管困难重重，但近年的很多研究仍然取得了很大的进展，相关药物的研发也已初见曙光。相关阅读：7.7亿美元！AriBio授权一款治疗阿尔茨海默病药物在国内营销权细胞系产品查询投稿丨商务合作转载丨加交流群往期推荐视角 | 纸面之外的药明康德2023年报Claudin18.2ADC赛道群雄逐鹿：3家率先进入III期临床下一个10亿美元重磅炸弹选手"裁员潮”仍在加剧：2月多家药企裁员点击下方“药研网”，关注更多精彩内容

临床3期临床结果临床2期抗体药物偶联物申请上市

2024-03-25

·药研网

7.7亿美元！AriBio授权一款治疗阿尔茨海默病药物在国内营销权

据businesswire媒体报道，近期AriBio宣布以高达7.7亿美元的价格签署了治疗早期阿尔茨海默病的研究药物AR1001在中国的独家营销权的授权协议。考虑到阿尔茨海默氏病药物在中国的市场竞争和销售策略，被许可方要求在商定时间之前不对外披露。该协议包括一笔1200亿韩元（约合9000万美元）预付款(不可退还)，交易总额高达55.9亿元人民币（约合7.7亿美元），包括里程碑付款和额外的特许权使用费。预付款将从2024年年中开始支付。AriBio部分管线AR1001是一种正在开发的磷酸二酯酶5型(PDE5)抑制剂，是一种治疗阿尔茨海默病的研究性口服药物。临床前研究已证实AR1001可抑制神经元凋亡和恢复突触可塑性，从而具有神经保护作用。AR1001在临床前模型以及2期临床试验中也展示了对高磷酸化tau蛋白的显著降低效果。AR1001-ADP3-US01 (NCT05531526)是一项3期双盲、随机、安慰剂对照、多中心试验，旨在评估AR1001在52周内对参与研究的早期阿尔茨海默氏症患者的疗效和安全性。该研究于 2022 年 12 月在美国启动，于 2023 年扩展到其他国家。此外，该临床试验正在等待中国和欧盟的监管部门批准。阿尔兹海默症药物市场规模鉴于阿尔茨海默病有着庞大的市场需求，被药物研发界视作“皇冠上的明珠”。目前，全球约有5000万人罹患阿尔兹海默症，预计到2050年，增加至1.52亿人。当前，全球每年用于治疗、护理阿尔兹海默症病人的费用已经达到1万亿美元，而这一数字将在2030年达到目前的两倍，可见阿尔兹海默症药物将具有广阔的市场。据统计，我国60岁以上人群中有983万AD患者、3877万轻度认知损害 (MCI) 患者，且有报告预计，到2025年，阿尔茨海默病患者将达到1550万人，到2030年进一步增至1950万人。随着中国阿尔茨海默病患病人数的不断增加，许多知名制药公司都在寻求开发安全有效的阿尔茨海默病口服治疗药物。迄今为止，AriBio已与Samjin Pharmaceutical合作，向其授予了1000亿韩元的韩国独家销售权。现在，这一合作已扩展到中国。AriBio首席执行官兼董事长Matthew (Jai Jun) Choung表示：“这项交易表明我们坚定不移地致力于开发有效的阿尔茨海默病治疗方法，而我们的合作伙伴将帮助AR1001在亚洲主要地区取得成功。我们将继续与亚洲国家、中东、南美以及欧洲和美国的其他潜在合作伙伴商讨，为我们的AR1001项目积累优势。”阿尔兹海默症药物国内布局有数据显示，2020年中国阿尔茨海默病诊断市场规模约217.5亿元预计到2025年这一市场将达到260.2亿元。国内布局AD赛道的药企较少，属于相对高需求、低竞争的蓝海赛道。今年1月9日，据国家药监局官网公示：日本卫材的仑卡奈单抗注射液获批上市，用于治疗由阿尔茨海默病引起的轻度认知障碍和阿尔茨海默病轻度痴呆。国内有先声药业、恒瑞医药、海正药业等都在积极围绕这一领域进行研发，试图分一杯羹。目前，齐鲁制药的盐酸美金刚口溶膜获得NMPA批准上市，海正药业的AD-35处于二期临床阶段，先声药业PQ912处于二期临床阶段，恒瑞医药SHR-1707处于一期临床阶段。图片来源：兴业证券在行业观察人士看来，中国阿尔茨海默病患者群体庞大，此领域或是“兵家必争之地”。细胞系产品查询投稿丨商务合作转载丨加交流群往期推荐一国产GLP-1药企递交IPO招股书，估值约8.3亿元人民币超40亿美元：上海Argo与Novartis达成多项目RNAi独家合作17 亿美元！强生与LegoChem就Trop2 靶向ADC的达成许可协议完整版：2023 全年药企裁员汇总点击下方“药研网”，关注更多精彩内容

引进/卖出临床2期临床3期

2024-03-24

·BioSpace

AriBio Licenses Exclusive Marketing Rights for AR1001 for Alzheimer’s Disease in China for $770 Million USD

SEONGNAM-SI, South Korea--(BUSINESS WIRE)-- AriBio Co., Ltd. (AriBio), announces signing of exclusive marketing rights for AR1001, an investigational drug for early Alzheimer’s disease, in China for up to $770 million USD. The term consists of a non-refundable upfront payment of 120 billion KRW (approximately 90 million USD), with the total deal summing up to 5.59 billion RMB (approximately 770 million USD) inclusive of milestone payments with additional royalties. The upfront payment will be paid starting from mid-2024. In response to the increasing Alzheimer’s disease population in China, prominent pharmaceutical companies have sought to develop safe and effective oral treatments for Alzheimer’s disease. To date, AriBio has partnered for exclusive marketing rights in South Korea with Samjin Pharmaceutical for 100 billion KRW. And now, the partnership has expanded to China, cumulating to 1.12 trillion KRW (approximately 840 million USD). Considering the market competition for Alzheimer’s drugs in China and the sales strategy, the licensee requested not to be disclosed until an agreed upon time. The global Phase 3 clinical trial for AR1001 in early Alzheimer’s disease patients (Polaris-AD) is on-going in the United States, United Kingdom, and South Korea. Furthermore, the clinical trial is awaiting regulatory approval in China and the European Union. This study will be conducted across 180 global sites. The first patient enrollment began in the United States in December 2022, and the rest of the regions are actively enrolling. Matthew (Jai Jun) Choung, CEO and Chairman of AriBio, stated, “This deal demonstrates our unwavering commitment to developing meaningful treatments for Alzheimer’s disease, and our partners will help position AR1001 for success in the major Asian territories. We are building momentum in our AR1001 program, as we continue to discuss with other potential partners in Asian countries, the Middle East, South America, as well as Europe and the United States.” About AR1001 AR1001 is a PDE5 inhibitor being developed as an investigational oral agent for the treatment of Alzheimer’s disease. Pre-clinical studies have confirmed neuroprotective effects of AR1001 via inhibiting neuron apoptosis and restoring synaptic plasticity. AR1001 has also demonstrated robust reduction of hyperphosphorylated tau proteins in pre-clinical models as well as in a Phase 2 trial. About AR1001-ADP3-US01 AR1001-ADP3-US01 (NCT05531526) is a Phase 3 double-blind, randomized, placebo-controlled, multi-center trial to evaluate the efficacy and safety of AR1001 over 52 weeks in participants with early Alzheimer’s disease. The study aims to assess the efficacy and safety of AR1001 in slowing the progression of Alzheimer’s disease through various cognitive and functional assessments. The details of the clinical trial are available at ClinicalTrials.gov. About AriBio AriBio Co., Ltd. is a biopharmaceutical company based in South Korea with offices in both South Korea and the United States. The company focuses on the development of novel therapies for neurodegenerative diseases. The company continues to expand its partnerships to accelerate the development of meaningful treatment options for neurodegenerative diseases. View source version on businesswire.com: Contacts Fred Kim fredkim@aribiousa.com Source: AriBio Co., Ltd. View this news release online at:

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药物(靶点)	适应症	全球最高研发状态

Stepronin	呼吸障碍更多	批准上市
硫酸软骨素钠/羟丙甲纤维素/氯化钠/氯化钾 ( ELA2 )	视疲劳更多	批准上市
AR-1005	路易体病更多	临床2期
SJP1804 ( NOX )	黄斑变性更多	临床1期
SJP1801	阿尔茨海默症更多	临床前