Aribio Completes Patient Recruitment for AR1001 Global Phase 3 Clinical Trial... Top-line Results to be Announced in Early Next Year

Aribio announced on the 25th that it has completed patient recruitment ahead of schedule for the global Phase 3 clinical trial ‘Polaris-AD’ of the oral Alzheimer’s disease treatment AR1001. High patient compliance and low dropout rates led to the early achievement of patient recruitment.

The Phase 3 clinical trial of AR1001 involves a total of 1,150 Alzheimer’s disease patients at over 200 clinical centers across 13 countries, including the United States, Canada, South Korea, China, the United Kingdom, and eight countries in the European Union (EU). The global principal investigator is Sharon Sha, director of the Dementia Center at Stanford University, and the principal investigator in South Korea is Professor Sangyoon Kim of the Department of Neurology at Bundang Seoul National University Hospital.

James Rock, Chief Clinical Officer of Aribio’s U.S. branch, stated, “There are currently no approved oral treatments for Alzheimer’s disease,” adding, “Recently approved single-antibody-based drugs are administered intravenously, which poses limitations in terms of safety and cost.”

He continued, “AR1001 is an oral formulation that is convenient to take and has established safety, which attracted significant interest in the global Phase 3 clinical trial and enabled rapid patient recruitment.”

Aribio plans to analyze the clinical results and announce the topline data in the first half of 2026, when the last patient dosing is completed.

Jaejun Jung, CEO of Aribio, emphasized, “The early completion of patient recruitment for the AR1001 global Phase 3 trial has greatly increased expectations for clinical success,” and added, “With the attention of major global pharmaceutical companies focused on us, we will carry a heavy responsibility and do our best to complete the trial and obtain approval.”

Meanwhile, Aribio is growing as the only domestic biotech company capable of independently conducting the entire global clinical process. It is currently pursuing a merger with Solux, a KOSDAQ-listed company.