AriBio said Tuesday the Ministry of Food and Drug Safety (MFDS) has approved a multi-country phase 3 clinical trial of AR1001, an investigational tablet to treat early Alzheimer’s disease.

With the approval, the company plans to conduct the study in 150 patients with Samjin Pharmaceutical in Korea. 

In February, the two companies agreed to jointly conduct clinical trials of the treatment, with Samjin having exclusive manufacturing and marketing rights.

The clinical trial will evaluate the safety and efficacy of the candidate in patients with early-stage Alzheimer's disease for 52 weeks.

AriBio’s ongoing multi-country phase 3 trial (project name Polaris-AD) aims to enroll 1,250 patients, including 600 patients in the U.S., 400 in Europe, 150 in Korea, and 100 in China.

Patients were first dosed in the U.S. last December, and the company is seeking phase 3 study approvals for AR1001 in Europe and China.

"Phase 3 is very important to confirm the efficacy of AR1001 that we saw in Phase 2," AriBio CEO Choung Jai-jun said. "It is an opportunity to verify whether the effects seen in the U.S. patient population are also seen in Koreans, Europeans, and Chinese patients."

AR1001 is a candidate for the treatment of dementia with multiple mechanisms of action, including inhibition of neuronal death and promotion of neurogenesis through activation of the CREB signaling pathway, enhancement of synaptic plasticity through activation of the Wnt signaling system, inhibition of toxic protein clearance and accumulation through activation of autophagy, and enhancement of blood-brain barrier permeability and cerebral blood flow.