AriBio Receives IND Approval from China’s NMPA for POLARIS-AD, a Phase 3 Trial for the Treatment of Early Alzheimer’s Disease
May 14 2024 - 3:16PM
Business Wire
AriBio Co., Ltd. (AriBio), a biotech company dedicated to
pioneering treatments for neurodegenerative diseases, announces
approval of the Investigational New Drug (IND) application by the
Center for Drug Evaluation (CDE) of China’s National Medical
Products Administration (NMPA) for the initiation of the Phase 3
Polaris-AD trial in China of AR1001 in early Alzheimer’s Disease
(AD) on May 11th, 2024.
The Phase 3 clinical trial will enroll early AD patients at up
to 20 clinical trial centers in China with consistent eligibility
criteria compared to other countries that are also enrolling
patients. Key evaluation indicators include Clinical Dementia
Rating Scale – Sum of Boxes (CDR-SB), Alzheimer's Disease
Assessment Scale-Cognitive Subscale (ADAS-Cog13),
Amsterdam-Activities of Daily Living Questionnaire (A-iADL-S-QV),
Geriatric Depression Scale (GDS), Mini-Mental State Examination
(MMSE), as well as changes in cerebrospinal fluid (CSF), imaging,
and plasma biomarkers.
Following the successful acceptance of the POLARIS-AD IND and
clinical trial applications in 11 countries, including the United
States, Korea, United Kingdom, Germany, France, Spain, Italy,
Denmark, Netherlands, the Czech Republic, and now China, AriBio
continues to demonstrate its global commitment to addressing the
urgent need for innovative therapies in the treatment of
Alzheimer's disease.
With the inclusion of China, a significant player in the global
pharmaceutical market, in the Phase 3 clinical trial development of
AR1001, AriBio continues to expand its reach and impact in the
fight against Alzheimer's disease. The trial targets an estimated
1,150 participants enrolled across over 200 clinical centers in 11
countries.
Dr. Jai Jun Choung, CEO of AriBio, expressed his enthusiasm
about this milestone, stating, “We are thrilled to receive the IND
approval for AR1001 in China, a major achievement that exemplifies
AriBio's unwavering dedication to advancing novel treatments for
Alzheimer's disease on a global scale. With IND approval in all
targeted countries, including China, we are one step closer to
offering hope to millions of patients worldwide.”
Looking ahead, AriBio is poised to commence the Phase 3 clinical
trial in China in Q3 2024. Dr. Choung reiterated AriBio's
dedication to success, stating, “As the first Korean
biopharmaceutical company to directly manage and conduct a global
Phase 3 clinical trial of this scale, we are committed to achieving
our mission with a sense of pride and responsibility. We are
grateful for the support and attention from each country
participating in our clinical trial and remain steadfast in our
pursuit of groundbreaking treatments for Alzheimer's disease.”
For more information about AriBio and its innovative pipeline of
therapies for neurodegenerative diseases, please visit
www.aribio.com.
About AR1001
AR1001 is a phosphodiesterase-5 (PDE5) inhibitor being developed
as an investigational oral agent for the treatment of Alzheimer’s
disease. Pre-clinical studies have confirmed neuroprotective
effects of AR1001 via inhibiting neuron apoptosis and restoring
synaptic plasticity, demonstrating multiple mechanisms of action
for disease modifying effects that may ameliorate the course of
AD.
About AR1001-ADP3-US01 (POLARIS-AD)
AR1001-ADP3-US01 (NCT05531526) is a Phase 3 double-blind,
randomized, placebo-controlled, multi-center trial evaluating the
efficacy and safety of AR1001 in patients with early Alzheimer’s
disease. 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.
Forward-Looking Statements:
This press release contains forward-looking statements that are
based on current expectations and beliefs and are subject to
several risks and uncertainties that could cause actual results to
differ materially from those described in the forward-looking
statements. Readers are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
of this release. AriBio undertakes no obligation to update any
forward-looking statement.
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Fred Kim Managing Director fredkim@aribiousa.com