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 24^th 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.”