Aribio Achieves 95% Voluntary Extension Study Participation Rate in Global Phase 3 Trial of AR1001, Surpassing 90% Progress Mark

by Jang Hyowon

Published 09 Mar.2026 08:13(KST)

Aribio Achieves 95% Voluntary Extension Study Participation Rate in Global Phase 3 Trial of AR1001, Surpassing 90% Progress Mark

Aribio announced on March 9 that more than 95% of patients who completed the global Phase 3 clinical trial (POLARIS-AD) of its oral Alzheimer's disease treatment AR1001 have chosen to participate in an additional extension study.

POLARIS-AD is a late-stage clinical trial targeting 1,535 patients with early-stage Alzheimer's disease at 230 institutions across 13 countries worldwide. The trial is designed so that, after the main 52-week study ends, patients can voluntarily decide whether to participate in an optional extension study.

With the overall clinical trial progress rate now exceeding 90%, the vast majority (95%) of patients who have completed the main trial have elected to participate in the additional one-year extension study, in which they will continue to receive the investigational drug. The company explained that this outcome demonstrates that patients, families, and medical staff have trust in the excellent efficacy, safety, and oral dosing convenience of AR1001 as experienced in actual treatment settings.

In particular, the dropout rate during the clinical trial was significantly lower than initially expected, indicating stability. This is considered an unusually high level of adherence for a large-scale global Alzheimer's disease clinical trial. Given that AR1001 has a differentiated profile compared to existing antibody therapies based on injections, this is expected to be a key factor in establishing the drug as a first-line treatment for Alzheimer's disease during the approval and commercialization process.

Fred Kim, President of Aribio USA, commented, "The voluntary participation rate in the extension study exceeded our expectations because patients and caregivers directly experienced the efficacy and safety of AR1001," adding, "As a result, we have manufactured additional clinical supplies."

He continued, "The global Phase 3 clinical trial is scheduled to complete dosing in the second quarter of this year, with topline results expected in the third quarter. The high extension study participation rate and the low dropout rate will provide an important foundation for increasing the reliability of the upcoming clinical results."

Aribio will present an overview of its Phase 3 clinical trial at the 2026 International Conference on Alzheimer's and Parkinson's Diseases (ADPD), to be held in Copenhagen, Denmark starting March 17. Sharon Sha, Professor of Neurology and Director of the Dementia Center at Stanford University and a world-renowned expert in Alzheimer's clinical research, will give a presentation on the overall status of AR1001's Phase 3 clinical trial and strategies for developing it as a first-line treatment for Alzheimer's disease.

In addition, the exploratory clinical results of the non-invasive brain stimulation medical device "GVD-01" will also be announced. The exploratory trial identified meaningful signals such as improvements in cognitive function and cerebral blood flow indicators in patients with early-stage Alzheimer's disease.