Aribio said on the 28th that it completed the last patient last visit (LPLV) in the global phase 3 trial (POLARIS-AD) of AR1001, an oral Alzheimer's disease treatment candidate. With this, the company officially wrapped up the phase 3 trial that has been underway for more than three years.
LPLV is the point at which the last dosed patient completes the final safety assessment, a key milestone that signifies the end of a clinical trial.
The trial is a global phase 3 study conducted in about 230 clinical sites across 13 countries, including the United States, Europe, Korea and China, targeting 1,535 patients with early Alzheimer's disease. On June 30, a total of 1,348 patients completed 52 weeks of dosing, and on the 27th, the last patient also finished the 4-week follow-up safety assessment.
With the trial concluded, the company plans to announce topline results after database lock (DB lock), which finalizes the data so it can no longer be modified following cleaning of data collected from clinical sites worldwide, and subsequent statistical analyses.
Aribio plans to first disclose the topline results as soon as the 52-week efficacy and safety analyses are completed, and to present detailed results at the Clinical Trials on Alzheimer's Disease (CTAD 2026) meeting in Boston on Nov. 16.
Chief Executive Jeong Jae-jun of Aribio said, "We have completed the 1,535-participant global phase 3 trial conducted in 13 countries as planned," and added, "We will now concentrate the company's full capabilities on ensuring data completeness and analytical accuracy, as this is the stage to prove the clinical value of AR1001 with data."
Meanwhile, more than 1,250 patients, or 95.5% of all participants, are taking part in the ongoing open-label extension (OLE) following the end of this trial. The company plans to evaluate long-term safety and efficacy for up to two years through July 2027 and use the results for regulatory review and commercialization.