AriBiohas unveiled its groundbreaking experience in independently conducting a global Phase 3 clinical trial for an Alzheimer’s treatment, involving 1,535 participants across 240 institutions in 13 countries. The company secured over 150 billion KRW (approximately 112.6 million USD) through exclusive regional licensing agreements to fund the clinical trial, showcasing its ability to execute large-scale multinational studies by combining in-house overseas clinical operations with external expertise.
On October 15, AriBio announced at the KIC 2026 International Conference held at the Lotte Hotel in Seoul that it shared insights from its global Phase 3 trial, POLARIS-AD, for its oral Alzheimer’s treatment candidate, AR1001.
Fred Kim, President of AriBio’s U.S. branch, led the presentation. He outlined the challenges and successes experienced by the biotech firm in conducting global late-stage trials, focusing on trial design, operational systems, utilization of specialized personnel, and innovative funding strategies.
POLARIS-AD is designed to evaluate the efficacy and safety of AR1001 in patients with early-stage Alzheimer’s disease. The study involved 1,535 participants who received either 30 mg of AR1001 or a placebo over 52 weeks. The primary endpoint was measured using the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB). Impressively, 1,348 participants (87.8%) completed the full treatment period.
AriBio took a hands-on approach, directly managing the trial design, regulatory strategies, and key operational decisions from its clinical operations team in San Diego, California. The company strategically utilized multiple clinical research organizations (CROs) based on regional and functional needs while deploying its own monitoring staff to oversee clinical trial sites and external partners across various countries. AriBio emphasized clear role distribution, standardized evaluator training, and rapid responses to on-site issues as key factors in their operational success.
Securing substantial funding to support large-scale clinical trials emerged as a significant challenge. AriBio reported that it leveraged over 150 billion KRW (approximately 112.6 million USD) in funding from AriBio Holdings and secured exclusive regional licensing agreements to cover the extensive clinical costs. This innovative approach allowed the company to maintain control over clinical development while granting commercialization rights to strategic partners.
The company also benefited from support provided by the Korea National Clinical Trial Support Foundation (KoNECT). AR1001 was selected as the inaugural project for the foundation’s public clinical trial support program in January 2023. KoNECT assisted with feasibility reviews for domestic trials, facilitated connections with research institutions, and provided consultations and recruitment support for potential participants. Notably, domestic participants accounted for about 13% of the total trial population, with 200 individuals involved.
Fred Kim, President of the U.S. branch, stated that completing this Phase 3 trial has allowed them to accumulate invaluable expertise across the entire process, from design to execution of multinational trials. This experience will serve as a solid foundation for the development of the future pipeline.
The eagerly anticipated top-line data from POLARIS-AD will be unveiled for the first time at the Alzheimer’s Clinical Trials International Conference (CTAD 2026) in Boston on November 16. Professor Sharon Sha from Stanford University is scheduled to present the groundbreaking findings during the opening session.
AriBio, founded in 2010, is a pioneering drug development company that has focused its efforts on the global Phase 3 trial of its oral Alzheimer’s treatment candidate, AR1001. Recently, the company has been highlighting its enhanced global drug development capabilities, drawing on its experience in independently leading and successfully completing large-scale multinational trials.