Aribio's "Oral Dementia Drug" Receives Approval for Phase 3 Clinical Trial in China... "Aiming to Achieve Approval in 11 Countries"

Aribio has received approval for the global Phase 3 clinical trial plan of AR1001, an oral treatment for Alzheimer's disease dementia, from all 11 target countries originally planned for the clinical trial.

Aribio 'AR1001' image [Photo by Aribio]

On the 14th, Aribio announced that it had obtained approval for the Phase 3 clinical trial plan of AR1001 from the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) of China. With this, Aribio has successfully received clinical trial plan approvals from regulatory agencies in all 11 countries where the Phase 3 trial is scheduled to be conducted, including China, the United States, South Korea, seven European Union (EU) countries (Germany, France, Spain, Italy, Denmark, the Netherlands, Czech Republic), and the United Kingdom.

The trial is planned to be conducted at over 200 clinical centers with a total of 1,150 participants. It will be a 52-week, double-blind, randomized, placebo-controlled, multicenter Phase 3 clinical trial to evaluate the efficacy and safety of AR1001 in patients with early Alzheimer's disease (AD). Through various cognitive and functional assessments, the trial will evaluate AR1001’s efficacy in improving cognitive function and slowing the progression of Alzheimer's disease, as well as its safety. The primary endpoints include the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB), approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), along with other cognitive scales and biomarker changes in cerebrospinal fluid and plasma.

As approvals for AR1001’s regulatory Phase 3 clinical trial plans have been finalized by country, Aribio aims to announce the top-line clinical results by 2026. CEO Jaejun Jeong of Aribio stated, "In response to the global common concern and urgent need for dementia treatment, the Phase 3 clinical trials of AR1001, an oral multi-mechanism drug, are receiving attention and support from various countries," adding, "We will do our best for the success of this new drug with the pride and responsibility of a Korean company."