AriBio Co., Ltd. Announces Strategic Collaboration with Kentucky Clinical Trial Laboratory (KCTL) to Expand Alzheimer’s Disease Testing
June 21 2024 - 12:50AM
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.
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AriBio Co., Ltd. Fred Kim,
Managing Director 4660 La Jolla Village Dr Suite 1070, San Diego,
CA 92122 Email: fredkim@aribiousa.com
KCTL Saeed A. Jortani, PhD,
DABCC, FADLM 201 East Jefferson Street (Suite 113) Louisville, KY
40245 Tel: 502-396-1381 Email: sjortani@kentuckyctl.com