The study is planning to enrol nearly 150 patients with early Alzheimer’s disease. Credit: CGN089 / Shutterstock.

The Korean Ministry of Food and Drug Safety (MFDS) has granted clearance to Aribio to initiate the Phase III Polaris-AD clinical trial of AR1001 to treat patients with dementia.

The international study will be carried out in collaboration with Samjin Pharmaceutical as part of the agreement signed in February to jointly conduct the Phase III studies in Korea.

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In this study, the safety and effectiveness of AR1001 will be assessed in early Alzheimer’s disease patients.

Nearly 150 patients are intended to be enrolled from major domestic medical institutions and dementia centres later. They will receive AR1001 orally for 52 weeks.

The National Clinical Trial Support Foundation (KoNECT), under the Ministry of Health and Welfare, has designated the study as the first public-interest clinical trial support target, in Korea.

Aribio CEO Jaejoon Jung said: “It is very meaningful to reconfirm the effect of AR1001 confirmed in Phase II clinical trial through this global Phase III trial, and it is important to verify whether the effect shown in the US patient group is the same in Koreans, Europeans and Chinese.

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“We are one step closer to commercialising an oral Alzheimer’s disease treatment for the first time, and including Korea in global clinical trials means that Korea is one of the first countries to commercialise AR1001.”

The company’s Polaris-AD project is currently ongoing with a total of 1,250 patients including 400 in Europe, 100 in China, 600 subjects in the US and the remaining in Korea.

It is also seeking approvals in Europe and China for AR1001 Phase III studies.

AR1001 is a PDE5 inhibitor that suppresses the advancement of dementia thereby improving the patient’s memory and cognitive function.

It also activates autophagy with multiple multi-mechanism effects to remove and accumulate toxic proteins.

In addition, AR1001 activates the signal transduction pathway to accelerate neuronal cell death and the Wnt signalling pathway for enhancing synaptic plasticity.