Aribio's 'Oral Dementia Drug' Approved for Phase 3 Clinical Trial in Korea

Aribio's oral dementia treatment 'AR1001' is gaining momentum as its global Phase 3 clinical trial 'Polaris-AD' has received Investigational New Drug (IND) approval not only in the United States but also domestically in South Korea.

Photo by Lee Chunhee

Aribio announced on the 29th that it has obtained domestic clinical trial approval for AR1001 from the South Korean Ministry of Food and Drug Safety. The global Phase 3 trial for AR1001 is planned to enroll a total of 1,250 participants: 600 in the United States, 400 in Europe, 150 in South Korea, and 100 in China. The IND was approved by the U.S. Food and Drug Administration (FDA) last year, and patient dosing is already underway. Following the domestic IND approval, applications for IND are being prepared for Europe and China as well.

The Phase 3 clinical trial of AR1001 in South Korea is being conducted jointly with Samjin Pharmaceutical, with whom Aribio has an agreement for joint domestic clinical trials, exclusive domestic sales rights, and final clinical trials and new drug commercialization. Approximately 150 early Alzheimer's disease patients in South Korea will be dosed for 52 weeks to evaluate safety and efficacy. According to the schedule, patient recruitment will soon begin at major domestic medical institutions and dementia centers.

Additionally, this clinical trial has been designated as the first public interest clinical trial supported by the Korea National Enterprise for Clinical Trials (KoNECT) under the Ministry of Health and Welfare, which is expected to provide active support to expedite patient recruitment.

Aribio’s AR1001 is being developed as the first oral dementia treatment with multiple mechanisms of action. It has a strong PDE5 inhibitory effect that suppresses dementia progression and improves patients’ memory and cognitive function. The drug’s multiple mechanisms include inhibition of neuronal cell death and promotion of neuronal generation through activation of the CREB signaling pathway within brain nerve cells, enhancement of synaptic plasticity via activation of the Wnt signaling pathway, removal and suppression of toxic protein accumulation through activation of autophagy, excellent blood-brain barrier permeability, and increased cerebral blood flow.

Jaejun Jung, CEO of Aribio, emphasized, “It is highly meaningful to reconfirm the effects of AR1001 observed in Phase 2 through this global Phase 3 trial. This is also an opportunity to verify whether the effects seen in the U.S. patient group are consistent among Koreans, Europeans, and Chinese.” He added, “We have taken one step closer to the first commercialization of an oral Alzheimer's disease treatment. Including South Korea in the global clinical trial signifies that the Republic of Korea will be one of the first countries to commercialize AR1001.”

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