AriBio Co., Ltd. and Fujirebio Diagnostics, Inc. Announce Milestone Achievement to Advance Biomarker Development for Alzheimer’s Disease and Neurodegeneration
15 Julio 2024 - 7:17PM
Business Wire
Fujirebio Holdings Inc., its wholly-owned subsidiary Fujirebio
Diagnostics, Inc., and AriBio Co., Ltd. announced today the
attainment of the first milestone in a strategic partnership to
advance the development of biomarkers for Alzheimer’s disease (AD)
and other neurodegenerative conditions. This milestone marks a key
achievement which provides Fujirebio access to clinical samples and
data collected as part of the ongoing Phase 3 Alzheimer’s disease
study, POLARIS-AD.
POLARIS-AD will enroll up to 1150 participants with early
Alzheimer’s disease using AriBio’s AR1001, a PDE5 inhibitor shown
to inhibit neuron apoptosis, promote neurogenesis, increase
neuroplasticity and stimulate autophagy activity to remove toxic
proteins. The Phase 3 study has now expanded into South Korea,
Europe, the United Kingdom and China.
Fujirebio, a trusted partner for high-quality in vitro
diagnostic (IVD) testing solutions and a historical pioneer in
neurodegenerative disease diagnostics, is committed to the
advancement of biomarkers to better diagnose Alzheimer’s disease.
Fujirebio was the first company to obtain a U.S. Food and Drug
Administration (FDA) authorized IVD test for Alzheimer’s disease in
May 2022, and has been a pioneer for over 25 years to advance the
field through innovation and commercialization of novel
neurodegenerative biomarkers.
“AriBio remains committed to advancing biomarker development in
the Alzheimer’s disease field, aiming to provide accurate and
meaningful diagnostics for clinicians, patients, and their
families. Early detection and timely initiation of treatment are
crucial for improving patient outcomes. As new biomarkers are
discovered and enhanced diagnostics become available in cerebral
spinal fluid and blood, these biomarkers will not only aid in
disease detection but also in monitoring disease progression and
treatment response,” commented James Rock, CCO of AriBio.
About AR1001-ADP3-US01
AR1001-ADP3-US01 (NCT05531526) is a 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
(https://clinicaltrials.gov/study/NCT05531526).
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 first-in-class treatment options and
advancements in the field of neurodegeneration.
About Fujirebio
Fujirebio, a member of H.U. Group Holdings Inc., is a global
leader in the field of high-quality IVD testing. It has more than
50 years’ accumulated experience in the conception, development,
production, and worldwide commercialization of robust IVD
products.
Fujirebio was the first company to develop and market
cerebrospinal fluid (CSF) biomarkers under the Innogenetics brand
over 25 years ago. Fujirebio remains the only company with such a
comprehensive line-up of manual and fully automated
neurodegenerative disease assays and consistently partners with
organizations and clinical experts across the world to develop new
pathways for earlier, easier and more complete neurodegenerative
diagnostic tools. More information can be found at
www.fujirebio.com/alzheimer.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240715994017/en/
James Rock - AriBio jimrock@aribiousa.com
Chris Dague - Fujirebio chris.dague@fujirebio-us.com