Aribio's Dementia Treatment 'AR1001' Shows Cognitive Improvement in US Phase 2 Clinical Trial

Aribio CI (Photo by Aribio)

[Asia Economy Reporter Chunhee Lee] Aribio announced on the 6th that the extension of the Phase 2 clinical trial of its Alzheimer's (dementia) treatment 'AR1001,' approved by the U.S. Food and Drug Administration (FDA), resulted in further improvement in patients' cognitive function.

Aribio conducted the Phase 2 trial of AR1001 over 12 months at 21 clinical centers in the United States. After completing the initial 6-month trial with 173 patients, the safety and efficacy of the drug were confirmed. The company explained that in the extension trial, which included 115 patients who completed an additional 6 months of treatment after applying for participation, the drug's effectiveness was more pronounced than in the first half.

Patients who took AR1001 alone without other medications for a total of 12 months showed improvements in the cognitive function assessment index (ADAS-Cog 13) compared to the placebo group: 1.6 points improvement in the 10 mg dosage group and 5.8 points in the 30 mg dosage group. For patients with mild dementia, who have high treatment demand, the 10 mg group improved by 2.2 points, and the 30 mg group improved by 8.7 points.

Especially, excluding cases of severe obesity, mild dementia patients who took AR1001 alone showed cognitive function assessment improvements of 2.2 points in the 10 mg group and 9.2 points in the 30 mg group. The 9.2-point improvement in the 30 mg group significantly exceeds the 5.03 points measured during the initial 6-month trial before the extension.

James Rock, head of Aribio's U.S. branch, evaluated the trial results, stating, "Unlike existing dementia symptom relief drugs, this confirms the potential of AR1001 as a disease-modifying treatment that improves cognitive function and its development potential as a first-line therapy to replace existing drugs."

Jaejun Jung, CEO of Aribio, said, "Based on the successful 12-month Phase 2 clinical trial results, we plan to have a meeting with the U.S. FDA after completing Phase 2, submit an Investigational New Drug (IND) application for Phase 3 within this year, and start Phase 3 clinical trials early next year. Additionally, we are pursuing a technology special listing."