AriBio has completed the final patient follow-up in the global Phase 3 clinical trial of its oral Alzheimer’s disease treatment candidate AR1001, marking the end of patient evaluations and the beginning of final data analysis.
The company announced on July 28 that the Last Patient Last Visit (LPLV) has been completed for POLARIS-AD, the global Phase 3 study evaluating AR1001 in patients with early-stage Alzheimer’s disease.
LPLV marks the point at which the final participant completes their last safety assessment and is considered one of the key milestones signaling the completion of a clinical trial.
POLARIS-AD enrolled 1,535 patients with early Alzheimer’s disease across approximately 230 clinical sites in 13 countries, including the United States, Europe, South Korea, and China.
According to AriBio, 1,348 participants had completed the full 52-week treatment regimen by the end of June, and the final patient completed their last safety follow-up visit on July 27.
With patient follow-up now complete, the study has entered the data analysis phase. AriBio is currently cleaning and validating clinical data collected from trial sites worldwide before conducting a database lock (DB Lock), final statistical analyses, and reviews of the study’s primary efficacy endpoints and safety data.
The company said it plans to release topline results from the 52-week study as soon as they become available. Detailed findings will then be presented at the Clinical Trials on Alzheimer’s Disease (CTAD) 2026 conference, scheduled to open in Boston on Nov. 16.
AriBio also reported strong participation in the trial’s open-label extension (OLE) study, with 95.5% of eligible participants choosing to continue treatment. More than 1,250 patients are currently receiving AR1001 and undergoing long-term evaluations.
The extension study is expected to conclude in July 2027, and its long-term safety and efficacy data are expected to support future regulatory reviews and commercialization efforts.
“We successfully completed our global Phase 3 trial involving 1,535 patients across 13 countries as planned,” said AriBio CEO Jung Jae-jun. “Our focus now is to demonstrate the value of AR1001 through robust clinical data, and we are concentrating our efforts on ensuring data integrity and analytical accuracy.”