Aribio Successfully Concludes National Seminar on Interim Phase 3 Results of AR1001 in Korea

Oral Alzheimer's Disease Treatment AR1001 Korea Clinical Researchers Full Seminar. Aribio

Aribio announced on the 25th that it has successfully concluded the full seminar for Korean clinical researchers of the oral Alzheimer's disease treatment AR1001.

At the seminar held on the 22nd at the Fairmont Ambassador Seoul, the company compared the results of the Phase 3 clinical trial of Kisunla, which recently received approval from the U.S. Food and Drug Administration (FDA). At this event, Aribio revealed blinded interim results indicating that AR1001 could demonstrate equal or superior therapeutic effects, confirming its potential to become a global blockbuster new drug.

The company has completed enrollment of a total of 1,535 patients across 13 countries. This is considered a successful achievement compared to the enrollment numbers for Eisai's Leqembi (1,734 patients) and Eli Lilly's Kisunla (1,182 patients). Notably, about 200 patients participated from Korea alone, which is seen as enhancing the reliability of the data and the potential for future commercialization.

In this interim analysis, for the primary endpoint of the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score, Kisunla showed a 37.7% rate of patients in the entire treatment group who did not experience disease progression, while AR1001 recorded 41.8% in a blinded analysis of 314 patients who completed treatment. In particular, 28.7% of patients showed symptom improvement after one year of treatment, and 15.9% of patients exhibited clear improvement.

No cases of ARIA (amyloid-related imaging abnormalities), such as brain edema or cerebral hemorrhage, which can occur with antibody injection therapies, were reported in the AR1001 clinical trial. Only 1.2% of patients discontinued the trial due to side effects.

Professor Kim Sangyun of Seoul National University Bundang Hospital (Korea clinical lead PI) stated, "Considering the quality of patient enrollment and the low likelihood of placebo intervention, this interim data is sufficiently encouraging and allows us to predict positive final results."

An Aribio representative said, "Despite challenging circumstances, we are completing clinical trials on par with global big pharma," and added, "We are determined to make AR1001 a global blockbuster new drug through the completion of clinical trials and the topline announcement next year."

Aribio is currently pursuing a merger with Kosdaq-listed company Solux, with the merger date set for November 4.