Aribio Dementia Treatment, Phase 3 Clinical Trial Expansion to Domestic Sites Planned

Aribio's oral dementia treatment global Phase 3 clinical trial will also be conducted in Korea.

Aribio CI
Photo by Aribio

Aribio announced on the 21st that it has completed the application for the global Phase 3 clinical trial plan (IND) of the dementia treatment 'AR1001' to the Korea Ministry of Food and Drug Safety. Once IND approval is obtained from the Ministry, about 150 patients will be recruited domestically.

Patient recruitment for the clinical trial will be conducted at major domestic medical institutions and dementia centers, centered on the Department of Neurology at Bundang Seoul National University Hospital. The overall clinical trial will be jointly conducted with Samjin Pharmaceutical, a technology management alliance partner.

The ongoing AR1001 Phase 3 clinical trial for early Alzheimer's disease, 'Polaris-AD,' currently underway with the U.S. Food and Drug Administration (FDA), began dosing the first patient in December last year and aims to recruit about 600 patients in the U.S. Recently, Aribio officially submitted a scientific pre-review application to the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) and plans to apply for a Phase 3 clinical trial with the EMA as well. Aribio envisions conducting clinical trials involving a total of 1,200 patients across the U.S., Korea, and Europe.

Jaejun Jeong, CEO of Aribio, said, "With the active willingness of medical staff to participate, inquiries for clinical participation from patients and families suffering from mild cognitive impairment (MCI) and mild Alzheimer's disease have been steadily coming in. We will strive to start the clinical trial promptly so that AR1001 can be delivered to more patients."

Sangyoon Kim, Professor of Neurology at Bundang Seoul National University Hospital, said, "With recent expectations for the final approval of the antibody injection drug Leqembi (generic name lecanemab), interest and development prospects for dementia treatments overall are increasing. We will do our best to ensure that the Phase 3 clinical trial is successfully completed so that AR1001 can be developed as soon as possible."

This content was produced with the assistance of AI translation services.