SEONGNAM-SI, South Korea & LOUISVILLE, Ky.--(BUSINESS WIRE)--AriBio Co., Ltd. (AriBio) announces the expansion of testing for Alzheimer’s disease by entering into a strategic collaboration with Kentucky Clinical Trial Laboratory (KCTL) for the testing of cerebral spinal fluid (CSF) to accurately and efficiently aid in the diagnosis of Alzheimer’s disease using the Lumipulse® system from FujireBio. Samples from AriBio’s POLARIS-AD (AR1001-ADP3-US01) study, a global, Phase 3 early Alzheimer’s disease trial in North America, European Union, United Kingdom, and Korea can be tested for Aβ42/40 ratio with the U.S. Food and Drug Administration (FDA) approved assay on the Lumipulse® system. AR1001-ADP3-US01 is a double-blind, randomized, placebo-controlled, multicenter registration trial to evaluate the efficacy and safety of AR1001 over 52 weeks of treatment in patients with early Alzheimer's disease. The trial is using the FDA and European Medicines Agency (EMA) accepted primary endpoint Clinical Dementia Rating Scale – Sum of Boxes (CDR-SB) and secondary endpoints including Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog 13), Amsterdam-Instrumental Activities of Daily Living Questionnaire (I-IADL), Geriatric Depression Scale (GDS), Mini-Mental Status Examination (MMSE), in addition to testing for changes in CSF and plasma biomarkers.
AriBio’s collaboration with KCTL will provide improved access, and efficient testing capabilities utilizing both CSF and plasma samples in FDA and EMA approved assays, and in promising new assays expected to advance our understanding of the evolving biomarker landscape in Alzheimer’s disease. As AriBio continues to develop therapeutics to treat neurodegenerative diseases including Alzheimer’s disease, having access to advanced diagnostics and laboratory testing is paramount to better understanding the patient’s journey, and the impact that therapeutic intervention has on biomarkers.
About AR1001-ADP3-US01
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. 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.
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 best-in-class treatment options and further advancements in the field of medicine.
About Kentucky Clinical Trial Laboratory (KCTL)
KCTL is a CLIA-Certified laboratory founded and operated in Louisville, Kentucky, United States since 2011. It provides clinical trials services to the in vitro diagnostics (IVD) and pharmaceutical manufacturers. It has participated in cardiovascular, neurological, infectious disease, hematology, coagulation and cancer biomarkers studies. Its services include patient screening and enrollment, sample collections and processing, laboratory testing and medical records reviews.
