AriBio, a Korean company focused on diagnosing and treating Alzheimer's disease, announced a strategic collaboration with the Kentucky Clinical Trial Laboratory (KCTL), based in Louisville,  KY, the U.S., to develop a new Alzheimer's disease diagnosis solution. 

While current diagnoses of Alzheimer's disease typically require amyloid PET scans or CSF analysis, there is a global push to develop blood-based diagnostic methods for greater convenience.

As a result, AriBio is planning to develop a new diagnostic method that goes with AR1001, its oral medication for Alzheimer's.

Under the accord, the two institutions plan to conduct Alzheimer's disease diagnostic studies using Fujirebio Diagnostics' Lumipulse system to expand cerebrospinal fluid (CSF) and plasma testing.

The collaboration will involve collecting and testing research samples from ongoing global phase 3 clinical trials in North America, the EU, the U.K., and Korea.

Utilizing FDA-approved tests, the Lumipulse system will measure the Aβ42/40 ratio, a critical biomarker in Alzheimer's diagnosis.

Established in 2011 and based in Louisville, KY, KCTL provides comprehensive clinical trial services for in vitro diagnostics (IVD) and pharmaceutical manufacturers. Their expertise spans vascular, neurological, infectious diseases, hematology, coagulation, and cancer biomarker research.

AriBio's multi-mechanism oral Alzheimer's treatment, AR1001, is currently undergoing a robust phase 3 clinical trial (POLARIS-AD) across 11 countries, including the U.S.

This 52-week, double-blind, randomized, placebo-controlled, multi-center study evaluates the efficacy and safety of AR1001 in patients with early-stage Alzheimer's disease.

Key assessment criteria include the Clinical Dementia Rating-Sum of Boxes (CDR-SB), 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), and changes in CSF and plasma biomarkers.

"Our partnership with KCTL marks a significant milestone in understanding and responding to the evolving biomarker landscape in Alzheimer's disease," AriBio CEO Choung Jai-jun said. "Alongside developing our oral therapeutic, we are committed to advancing new diagnostic tests using promising CSF and plasma samples, aiming for future U.S. FDA and EMA approvals."