Pharma Focus Europe

AriBio Co., Ltd. and Kentucky Clinical Trial Laboratory (KCTL) Collaborate to Expand Alzheimer’s Disease Testing

Saturday, June 22, 2024

AriBio Co., Ltd. (AriBio) has announced a strategic collaboration with Kentucky Clinical Trial Laboratory (KCTL) to expand Alzheimer’s disease testing. This partnership focuses on utilizing the Lumipulse® system from FujireBio for testing cerebral spinal fluid (CSF), aiming to improve the accuracy and efficiency of Alzheimer’s disease diagnosis. The collaboration allows samples from AriBio’s global Phase 3 trial, named POLARIS-AD (AR1001-ADP3-US01), conducted across North America, the European Union, the United Kingdom, and Korea, to be tested for Aβ42/40 ratio using FDA-approved assays on the Lumipulse® system.

AR1001-ADP3-US01 is a 52-week double-blind, randomized, placebo-controlled trial that evaluates the efficacy and safety of AR1001 in treating early Alzheimer's disease. The trial's primary endpoint is the Clinical Dementia Rating Scale – Sum of Boxes (CDR-SB), accepted by both the FDA and the European Medicines Agency (EMA). Secondary endpoints include the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog 13), Amsterdam-Instrumental Activities of Daily Living Questionnaire (I-IADL), Geriatric Depression Scale (GDS), and Mini-Mental Status Examination (MMSE), along with testing for changes in CSF and plasma biomarkers.

Through the collaboration with KCTL, AriBio aims to enhance access and efficiency in testing CSF and plasma samples using approved assays and innovative technologies, thus advancing our understanding of Alzheimer’s disease biomarkers. This partnership underscores AriBio’s commitment to developing therapeutics for neurodegenerative diseases, aiming to improve patient outcomes through better diagnostics and biomarker insights.



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