Aribio Expands AR1001 Phase 3 Clinical Trial in Korea to 250 Patients

Aribio, which is in the process of merging with Solux, announced on the 5th that it will expand the number of domestic Phase 3 clinical trial patients for the oral Alzheimer's treatment AR1001 by an additional 100, increasing the total to 250. The number of clinical trial centers will also increase from the existing 21 to 26.

The company explained that the high level of medical staff and the clinical trial center system in South Korea led to faster-than-expected patient recruitment and dosing. The Korea National Enterprise for Clinical Trials (KoNECT) designated AR1001 as the first public interest clinical trial support target, providing comprehensive support for patient recruitment, which also had a positive impact. Currently, medical staff from over 20 domestic clinical centers, including the Big 5 hospitals, are actively participating in the trial with a high understanding and strong drive for the clinical study.

The global Phase 3 clinical trial of AR1001 (study name 'Polaris-AD') is being conducted with approximately 1,150 patients across about 200 clinical centers in 13 countries, including South Korea, the United States, the United Kingdom, the European Union, and China. More than 50% of the dosing has been completed, and the company reported that safety issues and mid-trial patient dropout rates are low. This is evaluated as increasing the possibility of developing a safe and effective oral Alzheimer's treatment.

Jaejun Jeong, CEO of Aribio, said, “I would like to express my gratitude to the Korean medical staff, the Korea National Enterprise for Clinical Trials, patients, and their families who are dedicated to the clinical trial despite difficult circumstances to overcome dementia and develop treatments, which is a pressing social issue. We will accelerate new drug development and play a leading role in the birth of the first oral Alzheimer's disease drug.”