AriBio Co., Ltd. and Fujirebio Diagnostics, Inc. Announce Milestone Achievement 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 today the attainment of the first milestone in a strategic partnership to advance the development of biomarkers for Alzheimer’s disease (AD) and other neurodegenerative conditions. This milestone marks a key achievement which provides Fujirebio access to clinical samples and data collected as part of the ongoing Phase 3 Alzheimer’s disease study, POLARIS-AD.

POLARIS-AD will enroll up to 1150 participants with early Alzheimer’s disease using AriBio’s AR1001, a PDE5 inhibitor shown to inhibit neuron apoptosis, promote neurogenesis, increase neuroplasticity and stimulate autophagy activity to remove toxic proteins. The Phase 3 study has now expanded into South Korea, Europe, the United Kingdom and China.

Fujirebio, a trusted partner for high-quality in vitro diagnostic (IVD) testing solutions and a historical pioneer in neurodegenerative disease diagnostics, is committed to the advancement of biomarkers to better diagnose Alzheimer’s disease. Fujirebio was the first company to obtain a U.S. Food and Drug Administration (FDA) authorized IVD 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.

“AriBio remains committed to advancing biomarker development in the Alzheimer’s disease field, aiming to provide accurate and meaningful diagnostics for clinicians, patients, and their families. Early detection and timely initiation of treatment are crucial for improving patient outcomes. As new biomarkers are discovered and enhanced diagnostics become available in cerebral spinal fluid and blood, these biomarkers will not only aid in disease detection but also in monitoring disease progression and treatment response,” commented James Rock, CCO of AriBio.

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 (https://clinicaltrials.gov/study/NCT05531526).

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

Fujirebio, 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 was the first company to develop and market cerebrospinal fluid (CSF) biomarkers under the Innogenetics brand over 25 years ago. Fujirebio 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.