AriBio and Fujirebio Reach Key Milestone in Alzheimer’s Biomarker Research with Completion of Sample Collection from Phase 3 Trial
Fujirebio Holdings Inc., along with its wholly owned subsidiary Fujirebio Diagnostics, Inc., and biopharmaceutical company AriBio Co., Ltd., has announced the successful completion of a major milestone in their ongoing strategic partnership aimed at advancing the development of diagnostic biomarkers for Alzheimer’s disease and other neurodegenerative disorders. The companies confirmed the completion of a comprehensive prospective sample acquisition initiative, a critical component of their collaboration that is expected to significantly contribute to biomarker validation and development.
This achievement marks the culmination of AriBio’s commitment to supply both plasma and matched cerebrospinal fluid (CSF) samples collected from participants in its global Phase 3 clinical trial, known as POLARIS-AD. This study is evaluating the safety and efficacy of AR1001, AriBio’s investigational oral therapy for early Alzheimer’s disease. POLARIS-AD has successfully enrolled more than 1,150 patients across multiple international sites and has now reached its enrollment target.
What distinguishes this sample acquisition effort is its unprecedented scale and scientific rigor. The samples were collected not only at the trial’s baseline but also after 52 weeks of treatment, offering a valuable longitudinal dataset. Such dual-sample pairing—plasma and CSF—across multiple time points allows for robust comparative analyses that can aid in the identification, tracking, and validation of biomarkers associated with disease progression and treatment response.
This large, meticulously curated biobank represents one of the most comprehensive collections of biological samples ever assembled from patients with early-stage Alzheimer’s disease. As part of the ongoing commitment to deepen understanding of neurodegenerative disease biology, the trial will continue collecting additional samples during a 1-year extension phase. These added longitudinal samples will further enhance the scientific value of the biobank, enabling researchers to study disease trajectories over extended periods and evaluate how biomarkers change in response to therapeutic intervention.
Fujirebio Diagnostics, Inc., a global leader in the field of neurodegenerative diagnostics, is leveraging these well-characterized samples to accelerate the development of high-performance, blood-based biomarkers. The company’s expertise in in vitro diagnostics (IVDs), particularly for neurological conditions, has positioned it as a key player in the movement to bring non-invasive Alzheimer’s testing closer to clinical reality.
Founded on a legacy of innovation, Fujirebio was the first company to receive U.S. Food and Drug Administration (FDA) authorization for an in vitro diagnostic test to assess Alzheimer’s disease pathology. That landmark approval came in May 2022 and was built on decades of research in the measurement of proteins associated with neurodegeneration, including amyloid-beta and tau, two pathological hallmarks of Alzheimer’s. The availability of high-quality plasma samples from POLARIS-AD now provides a new opportunity for the company to validate emerging blood-based biomarkers that can serve as early indicators of amyloid accumulation or other disease mechanisms.
Amyloid pathology has long been a central focus of Alzheimer’s research. Traditional methods for detecting amyloid buildup in the brain—such as positron emission tomography (PET) imaging or lumbar punctures to obtain CSF—are expensive, invasive, and not always accessible in routine clinical settings. The ability to detect amyloid-related biomarkers using a simple blood test would mark a paradigm shift in the diagnosis and management of the disease, making it possible to screen patients earlier, monitor disease progression more conveniently, and potentially even personalize treatment.
“This collaboration exemplifies what is possible when companies with complementary expertise unite behind a shared scientific goal,” said a Fujirebio spokesperson. “By combining AriBio’s global clinical trial infrastructure and access to patient samples with Fujirebio’s diagnostic development capabilities, we are taking meaningful steps toward improving Alzheimer’s diagnostics.”
James Rock, Chief Commercial Officer of AriBio, expressed his gratitude to the many individuals and communities involved in the clinical trial, noting the essential role that patients and caregivers play in enabling medical progress.
“We can’t thank the patients, family members, and the Alzheimer’s community enough for such overwhelming support for this trial,” Rock stated. “AriBio will continue to conduct research and help expand biomarker development in this space with other committed parties. There is still a 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.”
The collaboration between AriBio and Fujirebio is emblematic of a broader trend in the pharmaceutical and diagnostics industries, where cross-sector partnerships are becoming increasingly essential to tackle complex diseases like Alzheimer’s. Biomarker development requires a convergence of capabilities—ranging from patient recruitment and sample collection to assay development and regulatory validation. Neither academic institutions nor companies can do it alone. Partnerships like this one help to close the translational gap between scientific discovery and clinical application.
For AriBio, the partnership also reinforces its strategic focus on delivering both therapeutic and diagnostic solutions to the Alzheimer’s space. The company’s lead asset, AR1001, is a novel phosphodiesterase-5 (PDE5) inhibitor that is being investigated for its potential neuroprotective and cognitive-enhancing effects. While the therapeutic trial continues to evaluate AR1001’s efficacy, the accompanying biomarker work provides a window into the underlying biological changes that occur with treatment. Ultimately, this data could support the use of biomarkers as surrogate endpoints, inform personalized treatment strategies, and enable earlier interventions before irreversible neuronal damage occurs.
Fujirebio, meanwhile, is focused on expanding its already robust pipeline of IVD tests. The company has a long-standing presence in Alzheimer’s diagnostics, including its pioneering work with CSF-based assays for total tau, phosphorylated tau, and amyloid-beta. With access to fresh longitudinal blood samples, Fujirebio can now work on refining its next generation of blood-based assays with the goal of achieving regulatory approvals in key global markets, including the U.S., Europe, and Asia.
As the field of Alzheimer’s research continues to evolve, the importance of high-quality biobanks cannot be overstated. They serve as the foundation for biomarker discovery, validation, and regulatory qualification. The POLARIS-AD biobank, supported by the AriBio-Fujirebio alliance, is likely to serve as a critical resource for years to come, enabling multiple lines of scientific inquiry beyond the original scope of the study.
Looking ahead, both companies affirmed their commitment to ongoing collaboration and to expanding access to the scientific resources generated through this partnership. Future efforts may include broader research collaborations, public-private partnerships, and data-sharing initiatives to accelerate progress across the Alzheimer’s research community.
With over 55 million people living with dementia worldwide—a number projected to triple by 2050—the urgency to find effective diagnostics and treatments has never been greater. Through this strategic alliance, AriBio and Fujirebio are contributing valuable tools and knowledge to the global effort to combat Alzheimer’s disease and improve the lives of patients and caregivers alike.
