Aribio's 'AR1001' Completes Global Clinical Trial Application Process

Aribio announced on the 26th that it has completed all Investigational New Drug (IND) application procedures for the ongoing global Phase 3 clinical trial 'Polaris-AD' of the oral Alzheimer's disease treatment 'AR1001'.

Aribio 'AR1001' image [Photo by Aribio]

Aribio is conducting the global Phase 3 clinical trial of AR1001 with a total of 1,250 patients, including 150 in Korea, 600 in the United States, 100 to 150 in China, and 400 in the UK and Europe. The clinical trial began in the United States at the end of last year and dosing is underway, while patient recruitment is ongoing in Korea with the support of the National Clinical Trial Support Foundation.

The Polaris-AD trial is planned to enroll a total of 1,250 patients, including 100 to 150 in China, 150 in Korea, 600 in the United States, and 400 in Europe. In Korea, IND approval was obtained from the Ministry of Food and Drug Safety last month, and in the United States, IND approval was granted by the Food and Drug Administration (FDA) last year, with patient dosing currently in progress. Following China in September, the IND was submitted to the UK at the end of last month, and IND submissions have recently been completed in eight countries under the jurisdiction of the European Medicines Agency (EMA), including France, Germany, Spain, Italy, Denmark, the Netherlands, and Czechoslovakia.

The European Phase 3 clinical trial, which is recruiting approximately 400 early Alzheimer's disease patients, was applied for in accordance with the new Clinical Trial Regulation (CTR) established by the EMA last year. The EU-CTR was created to integrate clinical trials conducted in the member states of the European Union (EU) and the European Economic Area (EEA) into a single operating system and to manage information transparently and publicly.

AR1001 aims to be an oral dementia treatment with multiple mechanisms of action. It is explained to have efficacy in inhibiting dementia progression and improving patients' memory and cognitive function through strong phosphodiesterase (PDE) 5 inhibitory activity. The mechanism can be broadly divided into three parts. First, it suppresses the intracellular production of amyloid-beta (Aβ) protein, which is considered one of the key factors in Alzheimer's dementia. While antibody therapies, which currently dominate dementia treatment, work by removing extracellular Aβ accumulated in the brain, AR1001, as a synthetic chemical drug, has a small molecular structure that allows it to penetrate cells and remove Aβ through autophagy, thereby inhibiting its accumulation.

Jaejun Jeong, CEO of Aribio, said, "Patient recruitment in the UK is expected to begin as early as February next year, and in the EU from March. With the multinational global Phase 3 clinical trial applications completed by continent, our domestic and international researchers and employees are doing their best to conduct the trials smoothly and swiftly and to generate clinical data under the best possible conditions.”

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