Aribio Completes Global Phase 3 Trial of AR1001... Topline Results to Be Announced in November
Final Patient Safety Follow-Up Completed
Topline Results to Be Released After Data Analysis
Detailed Phase 3 Results to Be Presented at CTAD in November
Aribio, a new drug development company, announced on July 28 that it has completed the last patient’s last visit (LPLV) in the global Phase 3 clinical trial ‘POLARIS-AD’ for its oral Alzheimer’s disease treatment candidate ‘AR1001’.
LPLV is a key milestone in clinical trials, marking the moment when the last patient who received the study drug completes their final safety assessment and adverse event review, thereby signaling the end of the trial.
POLARIS-AD is a global Phase 3 clinical trial conducted in 13 countries, including the United States, Europe, Korea, and China, across approximately 230 sites, and enrolled 1,535 patients with early Alzheimer’s disease. According to the company, as of the end of June, 1,348 patients completed 52 weeks of treatment, and the 4-week safety follow-up visit for the last patient was completed on July 27. Accordingly, the company has now started the steps for results analysis, including data refinement and validation, database lock (DB Lock), and statistical analysis, during the patient management phase.
Aribio plans to release the topline results as soon as the 52-week efficacy and safety analysis is completed. Detailed results are scheduled to be presented at the Clinical Trials on Alzheimer’s Disease (CTAD 2026) conference to be held in Boston, USA, this November.
A long-term open-label extension (OLE) study is also underway. According to the company, after the completion of the main trial, 95.5% of participants chose to enroll in the extension study, with more than 1,250 patients currently receiving treatment and evaluation. The OLE study is scheduled to be completed in July 2027.
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Jaewon Chung, CEO of Aribio, stated, "We have successfully completed the global Phase 3 trial with 1,535 participants in 13 countries as planned. We will now focus our efforts on database lock and statistical analysis to prove the clinical value of AR1001."
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