AriBio Receives EMA Phase 3 Clinical Trial Authorisation for AR1001 in Treatment of Alzheimer’s Disease (POLARIS-AD)

BMH Summary 

AriBio Co., Ltd.’s POLARIS-AD clinical trial:

  • EMA Authorization: AriBio received authorization from the European Medicines Agency (EMA) for POLARIS-AD, aligning with the FDA and MHRA.
  • Clinical Trial Approval: Final decision on April 24th, with approvals in Czech Republic, Denmark, France, Germany, Italy, Spain, and The Netherlands.
  • Global Participation: About 1,150 participants expected across 200 sites globally.
  • Trial Design: POLARIS-AD is a phase 3, double-blind, randomized, placebo-controlled trial for early Alzheimer’s disease with confirmed amyloid pathology.
  • Endpoints: Primary endpoint is the Clinical Dementia Rating Scale–Sum of Boxes (CDR-SB); secondary endpoints include ADAS-Cog 13, A-iADL, GDS, MMSE, and changes in CSF and plasma biomarkers.
  • AR1001: A PDE5 inhibitor with neuroprotective effects, being developed as an oral treatment for Alzheimer’s disease.
  • Company Focus: AriBio specializes in developing therapies for neurodegenerative diseases, including Alzheimer’s disease.

SEONGNAM-SI, South Korea–(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.

Contacts

Fred Kim
fredkim@aribiousa.com

Original press release can be found here.