[Edaily Reporter Song Young-doo] Aribio announced on the 25th that it has completed early patient recruitment for the global Phase 3 clinical trial of the oral Alzheimer’s drug AR1001, known as “Polaris-AD.” This early completion was driven by high compliance and a low dropout rate among trial participants.
The Phase 3 trial of AR1001 involves 1,150 Alzheimer’s patients across 200 clinical centers in 13 countries including the United States, Canada, South Korea, China, the United Kingdom, and eight member countries of the European Union (EU). The global lead clinical investigator is Sharon Sha, director of the Dementia Center at Stanford University, while the lead investigator for South Korea is Professor Sang-Yoon Kim from the Department of Neurology at Seoul National University Bundang Hospital.
James Rock, chief clinical officer of Aribio’s U.S. branch, stated, “To date, there are no approved oral Alzheimer’s treatments,” and added, “Recently approved antibody-based drugs are in the form of intravenous injections, which have limitations in terms of safety and cost.” He further emphasized that “AR1001, being an easily administrable and safe oral formulation, has garnered significant global interest in its Phase 3 clinical trials, allowing for swift patient recruitment.”
Aribio plans to announce the analysis of clinical results and topline data in the first half of 2026 when the administration of the last patient is completed.
Aribio CEO Jung Jae-joon highlighted, “The early completion of patient recruitment for the global Phase 3 trial of AR1001 significantly raises expectations for the trial’s success,” and asserted, “With the focus of major global pharmaceutical companies on our project, we will approach the completion of the trials and securing approval with a profound sense of responsibility.”
Meanwhile, Aribio is developing as the only domestic biotech capable of independently conducting the entire global clinical trial process. It is currently pursuing a merger with the KOSDAQ-listed company Solux (290690).