AriBio applies for Phase 3 clinical trials in China for oral dementia drug

South Korean clinical-stage biotech company AriBio Co. on Thursday said it applied for Phase 3 clinical trials on the anti-Alzheimer's candidate treatment AR1001 with the Center for Drug Evaluation of China's National Medical Products Administration.

Tests on AR1001 in China will be done on an estimated 100-150 people as part of AriBio's Phase 3 Polaris-AD clinical trials on the drug candidate in progress on 1,250 people worldwide.

"We decided to include China in our ongoing global Phase 3 clinical trials to lay the basis for entering the Chinese market," AriBio CEO Choung Jai-jun said. "This shows our firm commitment to the global development of new drugs that includes all major world markets."

AriBio is also preparing to apply for clinical trials in Europe under the goal of expanding Polaris-AD testing, which started in the US late last year, to South Korea, China and Europe.

In June, the company applied for scientific advice for the Phase 3 clinical test protocol of AR1001 to the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency. AriBio later received a written opinion from the CHMP agreeing overall with the company's Polaris-AD protocol and clinical trial plan.

AriBio will submit a proposal to conduct trials on the Continent in the second half of this year.

James Rock, AriBio's chief clinical operations officer and president of AriBio USA, said that for the success of its global Phase 3 trials, the company set up a system of hiring talented staff with extensive clinical experience at headquarters in South Korea and the American branch.

With the final clinical trials ongoing, he added, patients and their families who learned of AR1001's effectiveness are continuing to contact AriBio.

Write to In-Hyuk Park at hyuk@hankyung.com