The global Phase 3 clinical trial results for the oral Alzheimer's treatment candidate AR1001 will be unveiled at the world's largest Alzheimer's clinical development conference, CTAD 2026, in November. The topline results will be disclosed as soon as they are finalized, separate from the conference presentation.
On July 22, Aribio announced that the global Phase 3 trial, named POLARIS-AD, has been selected for the core oral presentation program at the 19th Alzheimer's Clinical Trials Conference, which will take place in Boston, USA, from November 16 to 19.
The results of the AR1001 Phase 3 trial will be presented during the first oral session on November 16, the opening day of the conference. The CTAD organizing committee has highlighted POLARIS-AD as one of the key clinical trial results to be announced this year.
The presentation is titled 'Global Phase 3 POLARIS-AD of AR1001 in Early Alzheimer's Disease Patients: 52-Week Efficacy Results and Safety from the Extension Phase.' The lead presenter will be Dr. Sharon Sha, the principal investigator of the AR1001 global Phase 3 trial and a clinical professor of neurology and neuroscience at Stanford University, who is a recognized authority in Alzheimer's research.
POLARIS-AD is a global Phase 3 trial conducted across approximately 230 clinical trial sites in 13 countries, including the United States, Canada, Europe, South Korea, and China, involving 1,535 patients with early Alzheimer's disease. The last patient completed 52 weeks of treatment on June 29, and data cleaning, database locking, and analysis procedures according to the pre-specified statistical analysis plan are currently underway.
At CTAD 2026, detailed clinical research results will be presented, including the primary efficacy and safety outcomes for the overall patient population and the monotherapy group, as well as specific evaluation variables, subgroup analyses, and safety data accumulated from the extension trial.
The completion of Aribio's global Phase 3 trial signifies its capability to independently design, operate, and manage large-scale multinational clinical trials.
Aribio CEO Jeong Jae-jun stated, 'The selection of POLARIS-AD as a major Phase 3 trial result to watch this year in the official CTAD program reflects the high interest of the global academic community in AR1001. We will transparently disclose the topline results as soon as they are available before the conference begins.' He added, 'Once the primary efficacy and safety indicators and detailed analysis results are presented at CTAD, we will promptly advance discussions with global regulatory agencies and prepare for new drug application submissions.'
* This article has been translated by AI.
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