AriBio Co., Ltd. Announces Strategic Collaboration with Kentucky Clinical Trial Laboratory (KCTL) to Expand Alzheimer's Disease Testing

SEONGNAM-SI, South Korea and LOUISVILLE, Ky., June 21, 2024–(BUSINESS WIRE)–AriBio Co., Ltd. (AriBio) announces the expansion of testing for Alzheimer’s disease by entering into a strategic collaboration with the Kentucky Clinical Trial Laboratory (KCTL) for cerebrospinal fluid (CSF) testing to accurately and efficiently aid in the diagnosis of Alzheimer’s disease. Alzheimer’s disease using the FujireBio Lumipulse® system. Samples from AriBio’s POLARIS-AD (AR1001-ADP3-US01) study, a global Phase 3 trial in early Alzheimer’s disease in North America, the European Union, the United Kingdom and Korea, can be tested for Aβ42/40 ratio with the US Food and Drug Administration. Test approved by the administration (FDA) on the Lumipulse® system. AR1001-ADP3-US01 is a multicenter, double-blind, randomized, placebo-controlled, registrational trial to evaluate the efficacy and safety of AR1001 over 52 weeks of treatment in patients with Alzheimer’s disease. Early Alzheimer’s. The trial uses the primary endpoint accepted by the FDA and the European Medicines Agency (EMA): the Clinical Dementia Rating Scale – Sum of Boxes (CDR-SB) and endpoints secondary, 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 State Examination (MMSE), in addition to testing for changes in CSF and plasma biomarkers.

AriBio’s collaboration with KCTL will provide enhanced access and efficient testing capabilities using both CSF and plasma samples in FDA and EMA approved assays, as well as promising new assays expected to advance our understanding of the evolving biomarker landscape in Alzheimer’s disease. As AriBio continues to develop treatments to treat neurodegenerative diseases, including Alzheimer’s disease, access to advanced diagnostics and laboratory testing is essential to better understand the patient journey and the impact of therapeutic intervention on biomarkers.

About AR1001-ADP3-US01

AR1001-ADP3-US01 (NCT05531526) is a phase 3, double-blind, randomized, placebo-controlled, multicenter trial to evaluate the efficacy and safety of AR1001 over 52 weeks in participants with Alzheimer’s disease. Early Alzheimer’s. The study aims to evaluate the effectiveness and safety of AR1001 in slowing the progression of Alzheimer’s disease through various cognitive and functional assessments. 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 is focused on developing novel therapies for neurodegenerative diseases, including Alzheimer’s disease. The company continues to expand its partnerships to accelerate better treatment options and further advancements in medicine.

About the Kentucky Clinical Testing Laboratory (KCTL)

KCTL is a CLIA certified laboratory founded and operated in Louisville, Kentucky, USA since 2011. It provides clinical testing services to in vitro diagnostics (IVD) and pharmaceutical manufacturers. He has participated in studies on cardiovascular, neurological, infectious, hematological, coagulation and cancer biomarkers. Its services include patient screening and recruitment, specimen collection and processing, laboratory testing, and medical record review.

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Contacts

AriBio Co., Ltd.
Fred Kim, general manager
4660 La Jolla Village Drive, Suite 1070,
San Diego, California 92122
Email: [email protected]

KCTL
Saeed A. Jortani, PhD, DABCC, FADLM
201 Jefferson Street East (suite 113)
Louisville, KY 40245
Tel: 502-396-1381
E-mail: [email protected]