AriBio Co., Ltd. and Fujirebio Diagnostics, Inc. Announce Completion of Sample Set for the Strategic Partnership Implemented to Advance Biomarker Development for Alzheimer’s Disease and Neurodegeneration

SAN DIEGO & TOKYO & MALVERN, Pa.--(BUSINESS WIRE)--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. 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.

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. 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.

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. 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.

“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,” commented James Rock, CCO of AriBio.

About 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. 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.

About 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.

About Fujirebio Diagnostics, Inc.

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.

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