Aribio has completed the last patient visit for its oral Alzheimer's treatment, AR1001, in the global Phase 3 trial known as POLARIS-AD. The company is now in the final stages of data refinement and analysis ahead of the topline results announcement.
On July 28, Aribio announced that the last patient in the Phase 3 trial, conducted across 13 countries, has completed their final safety follow-up visit, marking the end of the last patient last visit (LPLV).
LPLV is considered a key milestone in clinical trials, occurring when the last treated patient completes their final adverse event and safety assessments.
The POLARIS-AD trial is a large-scale Phase 3 study involving 1,535 early Alzheimer's patients across approximately 230 clinical trial sites in the United States, Europe, South Korea, and China. According to the company, as of the end of June, a total of 1,348 participants had completed 52 weeks of treatment, and the last treated patient also completed their scheduled four-week final safety follow-up visit on July 27.
With the completion of LPLV, the focus of the POLARIS-AD Phase 3 trial has shifted from patient management to data verification and result analysis. Aribio is currently refining the data collected from clinical trial sites worldwide and will conduct final checks on data quality, key evaluation variables, and safety information before proceeding with database lock (DB Lock) and statistical analysis.
The company expressed optimism about the topline results, noting that the baseline characteristics of the clinical patient group have shown homogeneity and disease-specific data compared to already approved antibody injections.
Aribio plans to prioritize the release of topline results as soon as the 52-week efficacy and safety data are available. Detailed clinical results are set to be presented at the opening session of the Clinical Trials on Alzheimer's Disease (CTAD 2026) conference in Boston on November 16.
The successful completion of this global Phase 3 trial signifies Aribio's capability to independently design, operate, and manage large-scale multinational clinical trials.
Jae-jun Jeong, CEO of Aribio, stated, "From now on, AR1001 must prove its value through data, not just expectations. We will clearly present the clinical value of AR1001 through the topline results and the CTAD presentation."
* This article has been translated by AI.
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