Fujirebio Holdings Inc., its wholly-owned subsidiary Fujirebio Diagnostics, Inc., and AriBio Co., Ltd. announced the completion of a prospective sample acquisition as part of the strategic partnership to advance the development of biomarkers for Alzheimer’s disease and other neurodegenerative conditions.

富士瑞比奥控股公司、其全资子公司富士瑞比奥诊断公司以及AriBio有限公司宣布，作为推进阿尔茨海默病及其他神经退行性疾病生物标志物开发的战略合作的一部分，已完成前瞻性样本的获取。

This milestone marks the fulfillment of AriBio’s commitment to provide plasma and matched cerebral spinal fluid samples from the ongoing Phase 3 trial in early Alzheimer’s disease, POLARIS-AD..

这一里程碑标志着AriBio履行了其承诺，即提供来自早期阿尔茨海默病正在进行的III期试验（POLARIS-AD）的血浆和匹配的脑脊液样本。

This ongoing Phase 3 study has enrolled over 1150 participants globally and attained the enrollment target. Considering the extensive collection of both plasma and cerebral spinal fluid, not just at baseline, but also following 52 weeks of treatment, this represents one of the largest sample banks worldwide in this population.

这项正在进行的第 3 阶段研究已在全球招募了 1150 多名参与者，并达到了招募目标。考虑到不仅在基线时，而且在 52 周治疗后都广泛收集了血浆和脑脊液，这代表了该人群中全球最大的样本库之一。

Samples will continue to be collected for an additional year as part of the 1-year extension phase of the trial to further supplement the biobank with longitudinal samples..

作为试验1年延长期的一部分，样本将继续收集一年，以进一步补充生物库的纵向样本。

Fujirebio Diagnostics, Inc., a trusted partner for high-quality in vitro diagnostic (IVD) testing solutions and a pioneer in neurodegenerative disease diagnostics, is dedicated to advancing biomarkers that aid in the assessment of amyloid pathology, a hallmark of Alzheimer's disease, and other neurodegenerative disorders.

富士瑞比奥诊断公司（Fujirebio Diagnostics, Inc.）是高品质体外诊断（IVD）测试解决方案的可信赖合作伙伴，同时也是神经退行性疾病诊断领域的先驱，致力于推进有助于评估阿尔茨海默病标志性特征——淀粉样蛋白病理及其他神经退行性疾病的生物标志物。

Fujirebio Diagnostics, Inc. was the first company to obtain an FDA-authorized in vitro diagnostic test for Alzheimer’s disease in May 2022, and has been a pioneer for over 25 years to advance the field through innovation and commercialization of novel neurodegenerative biomarkers. The well characterized plasma samples obtained from AriBio’s ongoing Phase 3 trial supported Fujirebio Diagnostics, Inc.’s clinical performance evaluation of blood-based biomarkers for diagnostic use to assess amyloid pathology..

富士瑞比奥诊断公司于2022年5月成为首家获得FDA授权的阿尔茨海默病体外诊断测试的公司，并且在通过创新和商业化新型神经退行性生物标志物推动该领域发展方面，已经引领行业超过25年。AriBio正在进行的第三阶段试验中获得的特征明确的血浆样本，支持了富士瑞比奥诊断公司对基于血液的诊断用途生物标志物进行临床性能评估，以评估淀粉样蛋白病理。

“We can’t thank the patients, family members and the Alzheimer’s community enough for such overwhelming support for this trial. AriBio will continue to conduct research and help expand biomarker development in this space with other committed parties. There is still tremendous need for understanding disease progress and patient responses to treatment.

“我们无法充分感谢患者、家属和阿尔茨海默病社区对该试验的如此压倒性的支持。AriBio 将继续开展研究，并与其他致力于此领域的相关方合作，推动生物标志物的开发。对于理解疾病进展和患者对治疗的反应，仍然存在巨大的需求。”

We hope these samples can be utilized to move us closer to answering these important questions,” commented James Rock, CCO of AriBio..

“我们希望这些样本能够被利用，让我们更接近回答这些重要问题，”AriBio的首席文化官詹姆斯·洛克评论道。

About AR1001-ADP3-US01

关于 AR1001-ADP3-US01

POLARIS-AD (AR1001-ADP3-US01 [NCT05531526]) is 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. This study aims to assess the efficacy and safety of AR1001 in slowing the progression of Alzheimer's disease through various cognitive and functional assessments.

POLARIS-AD（AR1001-ADP3-US01 [NCT05531526]）是一项为期52周的III期双盲、随机、安慰剂对照、多中心试验，旨在评估AR1001在早期阿尔茨海默病患者中的疗效和安全性。该研究旨在通过多种认知和功能评估，检验AR1001在延缓阿尔茨海默病进展方面的有效性和安全性。

The details of the clinical trial are available at ClinicalTrials.gov and the trial is expected to have topline read out by Q2/Q3 in 2026..

该临床试验的详细信息可在ClinicalTrials.gov查询，预计将在2026年的第二或第三季度公布主要结果。

About AriBio

关于AriBio

AriBio Co., Ltd. is a biopharmaceutical company based in South Korea with offices in the United States. The company focuses on the development of novel therapies for neurodegenerative diseases including Alzheimer’s disease. The company continues to expand its partnerships to accelerate first-in-class treatment options and advancements in the field of neurodegeneration..

AriBio Co., Ltd.是一家总部位于韩国的生物制药公司，在美国设有办事处。该公司专注于开发针对神经退行性疾病（包括阿尔茨海默病）的新型疗法。公司不断拓展合作关系，以加速首创新药治疗选择及在神经退行性疾病领域的进步。

About Fujirebio Diagnostics, Inc.

关于富士瑞比奥诊断公司

Fujirebio Diagnostics, Inc., a member of H.U. Group Holdings Inc., is a global leader in the field of high-quality IVD testing. It has more than 50 years’ accumulated experience in the conception, development, production, and worldwide commercialization of robust IVD products.

富士瑞比奥诊断公司（Fujirebio Diagnostics, Inc.），作为H.U.集团控股公司的一员，是高品质体外诊断（IVD）检测领域的全球领导者。公司在构思、开发、生产以及强大的IVD产品全球商业化方面拥有超过50年的累积经验。

Fujirebio Diagnostics, Inc. was the first company to develop and market CSF biomarkers under the Innogenetics brand over 25 years ago. Fujirebio Diagnostics, Inc. remains the only company with such a comprehensive line-up of manual and fully automated neurodegenerative disease assays and consistently partners with organizations and clinical experts across the world to develop new pathways for earlier, easier and more complete neurodegenerative diagnostic tools.

富士瑞比奥诊断公司是首家在25年前开发并销售脑脊液生物标志物的公司，当时使用的是Innogenetics品牌。富士瑞比奥诊断公司仍然是唯一一家拥有如此全面的手动和全自动神经退行性疾病检测方法的公司，并且始终与全球的组织和临床专家合作，开发更早期、更简便、更完整的神经退行性疾病诊断工具的新途径。

More information can be found at www.fujirebio.com/alzheimer..

更多信息请访问 www.fujirebio.com/alzheimer。

Contacts

联系人

James Rock, CCO, AriBio

詹姆斯·洛克，首席文化官，阿里生物

[email protected]

电子邮件地址

Source: businesswire.com

来源：businesswire.com