AriBio said on Tuesday that it applied for a global phase 3 study of AR1001, an oral treatment candidate for Alzheimer’s disease, to the European Medicines Agency (EMA).

The phase 3 trial, Polaris-AD, will enroll more than 400 patients with early Alzheimer’s disease in European countries including the U.K., France, Germany, Spain, Italy, Denmark, the Netherlands, the Czech Republic, and Slovakia. In November, the company submitted the trial application to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K. 

The latest phase 3 study was designed in line with the EMA’s new clinical trials regulation (CTR) created in 2022, the Korean biotech company said. The EU-CTR is intended to unify clinical trials conducted in each country of the EU-EEA into a single operating system and make the information publicly transparent.

The global phase 3 Polaris-AD trial will enroll 1,250 patients in total. Following approval of the phase 3 trial plan by the U.S. FDA in late 2022, the company is recruiting patients and dosing the drug candidate at more than 60 clinical centers in the U.S.

In Korea, the study has been designated by the government as a public benefit clinical trial. AriBio is recruiting patients on the Korea National Enterprise for Clinical Trials (KoNECT) portal, operated under the Ministry of Health and Welfare. 

The company also submitted a phase 3 trial plan to China's National Medical Products Administration (NMPA) and is awaiting approval.

AriBio CEO Choung Jai-jun said he expects patient recruitment to begin as early as February next year in the U.K. and March in the EU.

"Now that our global phase 3 application is complete, our researchers and employees worldwide are working hard to ensure a smooth and efficient clinical trial process, aiming to generate the best possible clinical data," he said.