EMA authorises AriBio’s Phase III clinical trial for AD


On 29 April, the biopharmaceutical company AriBio announced authorisation from the European Medicines Agency (EMA) for its POLARIS-AD Phase III clinical trial for early Alzheimer's disease (AD). This follows previous approvals by the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA). The final decision from EMA was completed on 24 April allowing the trial to proceed in Czech Republic, Denmark, France, Germany, Italy, Spain and the Netherlands. The trial is expected to enrol 1,150 participants across 200 sites globally. POLARIS-AD is a double-blind, randomised and placebo-controlled study evaluating the efficacy and safety of AR1001 in treatment of people with early AD with confirmed amyloid pathology. 

AR1001 is a small molecule that has demonstrated its potential as a therapeutic agent for AD via its poly-pharmacological characteristics with multiple mechanisms to ameliorate AD pathology. POLARIS-AS utilises the Clinical Dementia Rating Scale–Sum of Boxes (CDR-SB) as its primary endpoint, a measure accepted by both the FDA and EMA. Secondary endpoints include Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog 13), Geriatric Depression Scale (GDS), Amsterdam-Instrumental Activities of Daily Living Questionnaire (A-iADL), Mini-Mental Status Examination (MMSE), and changes in plasma and cerebral spinal fluid (CSF) biomarkers.