AriBio Co., Ltd. and Fujirebio Diagnostics, Inc. have announced the successful completion of a prospective sample acquisition as part of their strategic partnership focused on advancing biomarker development for Alzheimer's disease and other neurodegenerative conditions. This milestone represents the fulfillment of AriBio's commitment to provide plasma and matched cerebral spinal fluid samples from their ongoing Phase 3 POLARIS-AD trial in early Alzheimer's disease.
The Phase 3 study has successfully enrolled over 1,150 participants globally, reaching its target enrollment. What makes this collection particularly valuable is the extensive gathering of both plasma and cerebrospinal fluid samples not only at baseline but also following 52 weeks of treatment. This comprehensive approach has resulted in one of the largest sample banks worldwide for this specific patient population. The biobank will continue to grow as additional samples are collected during the trial's one-year extension phase, further enhancing the longitudinal data available to researchers.
James Rock, Chief Commercial Officer of AriBio, expressed gratitude to the participants: "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. We hope these samples can be utilized to move us closer to answering these important questions."
Advancing Diagnostic Capabilities for Alzheimer's Disease
Fujirebio Diagnostics, a pioneer in neurodegenerative disease diagnostics, has established itself as a trusted partner for high-quality in vitro diagnostic testing solutions. The company has been at the forefront of Alzheimer's research for over 25 years and made history in May 2022 as the first company to obtain FDA authorization for an in vitro diagnostic test for Alzheimer's disease.
The well-characterized plasma samples obtained from AriBio's ongoing Phase 3 trial are supporting Fujirebio's clinical performance evaluation of blood-based biomarkers for diagnostic use in assessing amyloid pathology, a hallmark of Alzheimer's disease. This work represents a significant step toward developing less invasive diagnostic tools for neurodegenerative conditions.
The POLARIS-AD Clinical Trial
The POLARIS-AD trial (AR1001-ADP3-US01 [NCT05531526]) is a Phase 3 double-blind, randomized, placebo-controlled, multi-center study evaluating the efficacy and safety of AR1001 over 52 weeks in participants with early Alzheimer's disease. The study aims to assess whether AR1001 can slow the progression of Alzheimer's disease through various cognitive and functional assessments.
The trial is expected to produce topline results by the second or third quarter of 2026. Complete details of the clinical trial are available on ClinicalTrials.gov.
Collaborative Approach to Neurodegenerative Research
This partnership between AriBio and Fujirebio exemplifies the collaborative approach needed to address the complex challenges of neurodegenerative diseases. AriBio, a biopharmaceutical company based in South Korea with offices in the United States, focuses on developing novel therapies for neurodegenerative diseases, particularly Alzheimer's disease. The company continues to expand its partnerships to accelerate first-in-class treatment options and advancements in neurodegeneration research.
Fujirebio Diagnostics, a member of H.U. Group Holdings Inc., brings more than 50 years of experience in the development and worldwide commercialization of robust in vitro diagnostic products. The company was the first to develop and market cerebrospinal fluid biomarkers under the Innogenetics brand over 25 years ago and remains the only company with such a comprehensive lineup of manual and fully automated neurodegenerative disease assays.
Implications for Future Alzheimer's Research
The completion of this sample collection represents a significant advancement in the field of Alzheimer's research. The extensive biobank created through this partnership will provide researchers with valuable resources to better understand the progression of Alzheimer's disease and evaluate the effectiveness of potential treatments.
As the global burden of Alzheimer's disease continues to grow with an aging population, the development of reliable biomarkers for early detection and treatment monitoring becomes increasingly critical. The collaboration between AriBio and Fujirebio Diagnostics demonstrates a commitment to addressing this urgent medical need through innovative research and development approaches.
