AriBio Receives EMA Phase 3 Clinical Trial Authorisation for AR1001 in Treatment of Alzheimer’s Disease (POLARIS-AD)
April 28 2024 - 8:10PM
Business Wire
AriBio Co., Ltd. (AriBio) announced authorisation from the
European Medicines Agency (EMA) for POLARIS-AD (AR1001-ADP3-US01),
a global, phase 3, early Alzheimer’s disease clinical trial. EMA
now aligns with the U.S. Food and Drug Administration (FDA) and UK
Medicines and Healthcare Products Regulatory Agency (MHRA) on the
Clinical Trial Authorisation of POLARIS-AD.
The final decision from EMA was completed on April 24th with
clinical trial approvals in the following member states: Czech
Republic, Denmark, France, Germany, Italy, Spain and The
Netherlands. Currently, 1,150 participants are expected to be
randomized into the Phase 3 clinical trial across 200 sites
globally.
POLARIS-AD is a double-blind, randomized, placebo-controlled,
multi-center registration trial evaluating the efficacy and safety
of AR1001 (Mirodenafil) in treatment of patients with early
Alzheimer’s disease (AD) with confirmed amyloid pathology. This
trial utilizes the U.S. Food and Drug Administration (FDA) and EMA
accepted primary endpoint, Clinical Dementia Rating Scale–Sum of
Boxes (CDR-SB), as well as secondary endpoints including
Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13
(ADAS-Cog 13), Amsterdam-Instrumental Activities of Daily Living
Questionnaire (A-iADL), Geriatric Depression Scale (GDS),
Mini-Mental Status Examination (MMSE), in addition to changes in
cerebral spinal fluid (CSF) and plasma biomarkers.
James Rock, the Chief Clinical Officer of AriBio stated,
“Following the acceptance of the POLARIS-AD in the United Kingdom
(UK), the expansion into the additional European countries is
another milestone for the registration program for AR1001. This
acceptance represents the fourth region that will be actively
screening and enrolling participants starting from Q2’2024. The
company has committed significant resources to expeditiously and
efficiently expand the footprint of the phase 3 program into these
regions. This coupled with strong interest for alternative
treatment options for patients with AD has fueled global interest
in AR1001. Operating this study globally makes the asset extremely
attractive for worldwide access should efficacy and safety be
demonstrated.”
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.
European Medicines Agency (EMA) aligns with the U.S. Food and
Drug Administration (FDA) and UK Medicines and Healthcare Products
Regulatory Agency (MHRA) on the Clinical Trial Authorisation of
POLARIS-AD, a Phase 3 Early Alzheimer’s Disease Trial Sponsored by
AriBio Co., Ltd.
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Fred Kim fredkim@aribiousa.com