Aribio Receives European Approval for Phase 3 Clinical Trial of Oral Dementia Drug

Aribio announced on the 29th that it has received approval from the European Medicines Agency (EMA) for the global Phase 3 clinical trial (Polaris-AD) plan of AR1001, an oral treatment for Alzheimer's disease under development.

Photo by Lee Chunhee

This Phase 3 trial is being conducted as a global clinical study encompassing seven European Union countries recently approved (Germany, France, Spain, Italy, Denmark, the Netherlands, Czech Republic), as well as the United States, the United Kingdom, South Korea, and China. Including the United Kingdom, where the trial has already started, the study is being conducted in 70 clinical centers across 8 European countries, targeting 300 participants. The total clinical trial scale aims for 1,150 participants across approximately 200 clinical centers in 11 countries.

The trial is a 52-week, double-blind, randomized, placebo-controlled, multicenter Phase 3 study designed to evaluate the efficacy and safety of AR1001 in patients with early Alzheimer's disease (AD). Through various cognitive and functional assessments, the study evaluates AR1001’s ability to improve cognitive function and slow the progression of Alzheimer's disease, as well as its safety. Key endpoints include the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB), approved by both the U.S. Food and Drug Administration (FDA) and EMA, along with other cognitive scales and biomarker changes in cerebrospinal fluid and plasma.

James Rock, Chief Clinical Officer (CCO) of Aribio’s U.S. branch, stated, "The expansion of the Phase 3 clinical trial to seven European countries will be a significant milestone for patient enrollment. With the global surge in treatment demand for Alzheimer's disease, international interest in AR1001, a multi-mechanism oral therapy, has greatly increased."

Jaejun Jung, CEO of Aribio, said, "With the Phase 3 trial already actively underway in the United States, the expansion of the trial into Europe, a major market and a key pillar of the global market, is expected to have a positive effect on ongoing global licensing negotiations."

This content was produced with the assistance of AI translation services.