Aribio has revealed its experience completing the global Phase 3 trial of its oral Alzheimer's treatment candidate, AR1001, known as POLARIS-AD.
On October 15, Aribio shared insights on the trial's design, operation, and funding at the KIC 2026 International Conference held at the Lotte Hotel in Seoul. The presentation was led by Fred Kim, head of Aribio's U.S. branch.
KIC is an annual international academic event organized by the Korea National Clinical Trial Center (KoNECT) in collaboration with the Ministry of Health and Welfare and the Ministry of Food and Drug Safety. The conference focuses on sharing global trends in new drug development and clinical trials, fostering collaboration among pharmaceutical and biotech companies, regulatory agencies, and research institutions.
Kim stated, "Completing this Phase 3 trial has allowed us to accumulate experience across the entire process of multinational clinical trial design and execution. This will serve as a foundation for the development of our subsequent pipeline."
POLARIS-AD is a global Phase 3 trial assessing the efficacy and safety of AR1001 in patients with early-stage Alzheimer's disease. A total of 1,535 participants from 240 institutions across 13 countries were involved, receiving either 30 mg of AR1001 or a placebo over 52 weeks.
The primary endpoint was the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB), which evaluates the severity of dementia symptoms and daily functioning. Of the total participants, 87.8%, or 1,348 individuals, completed the treatment period.
In South Korea, 200 participants were randomly assigned, accounting for approximately 13% of the total. AR1001 was selected in January 2023 for KoNECT's first public clinical trial support program, which provided assistance for feasibility reviews, connections with research institutions, and recruitment support for interested participants.
Aribio conducted trial design, regulatory strategy, and key operational decisions from its clinical operations organization in San Diego, utilizing multiple clinical research organizations (CROs) regionally and functionally while deploying its own monitoring staff to manage trial sites and external partners across 13 countries.
The clinical trial costs were covered through support from Aribio Holdings and exclusive licensing agreements in various global regions. Aribio received over 150 billion won through these licensing agreements, which were used to fund the POLARIS-AD trial.
The company emphasized that while it transferred commercialization rights regionally, it retained control over development.
Meanwhile, the top-line results of POLARIS-AD will be unveiled on November 16 at the Clinical Trials on Alzheimer's Disease (CTAD 2026) conference in Boston, where Professor Sharon Sha from Stanford University is scheduled to present during the opening session.
On October 15, Aribio shared insights on the trial's design, operation, and funding at the KIC 2026 International Conference held at the Lotte Hotel in Seoul. The presentation was led by Fred Kim, head of Aribio's U.S. branch.
KIC is an annual international academic event organized by the Korea National Clinical Trial Center (KoNECT) in collaboration with the Ministry of Health and Welfare and the Ministry of Food and Drug Safety. The conference focuses on sharing global trends in new drug development and clinical trials, fostering collaboration among pharmaceutical and biotech companies, regulatory agencies, and research institutions.
Kim stated, "Completing this Phase 3 trial has allowed us to accumulate experience across the entire process of multinational clinical trial design and execution. This will serve as a foundation for the development of our subsequent pipeline."
POLARIS-AD is a global Phase 3 trial assessing the efficacy and safety of AR1001 in patients with early-stage Alzheimer's disease. A total of 1,535 participants from 240 institutions across 13 countries were involved, receiving either 30 mg of AR1001 or a placebo over 52 weeks.
The primary endpoint was the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB), which evaluates the severity of dementia symptoms and daily functioning. Of the total participants, 87.8%, or 1,348 individuals, completed the treatment period.
In South Korea, 200 participants were randomly assigned, accounting for approximately 13% of the total. AR1001 was selected in January 2023 for KoNECT's first public clinical trial support program, which provided assistance for feasibility reviews, connections with research institutions, and recruitment support for interested participants.
Aribio conducted trial design, regulatory strategy, and key operational decisions from its clinical operations organization in San Diego, utilizing multiple clinical research organizations (CROs) regionally and functionally while deploying its own monitoring staff to manage trial sites and external partners across 13 countries.
The clinical trial costs were covered through support from Aribio Holdings and exclusive licensing agreements in various global regions. Aribio received over 150 billion won through these licensing agreements, which were used to fund the POLARIS-AD trial.
The company emphasized that while it transferred commercialization rights regionally, it retained control over development.
Meanwhile, the top-line results of POLARIS-AD will be unveiled on November 16 at the Clinical Trials on Alzheimer's Disease (CTAD 2026) conference in Boston, where Professor Sharon Sha from Stanford University is scheduled to present during the opening session.
* This article has been translated by AI.
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