alzheimer's curable? oral treatments for alzheimer's
Alzheimer's Disorder Treatment AR1001.
Korea·China are also looking forward to Alzheimer's treatment ↑
Aribio Completes European Clinical Trial Application for Global Phase 3 Alzheimer's Disorder Treatment AR1001.
AriBio announced on December 26 that it has completed the European clinical trial application for its global Phase 3 clinical trial of oral Alzheimer's disorder treatment(Alzheimer's disease) AR1001, which is currently in progress.
The European Phase 3 clinical trial of AR1001 is being conducted in eight countries, including the United Kingdom (MHRA), which completed its application at the end of November, as well as France, Germany, Spain, Italy, Denmark, the Netherlands, and Czech Republic. The trial will recruit approximately 400 patients with early Alzheimer's disease.
The European Phase 3 clinical trial protocol was submitted to the European Medicines Agency (EMA) in accordance with the new Clinical Trials Regulation (CTR) that was established in 2022. The EU-CTR was created to unify clinical trials conducted in each country of the EU and EEA into a single operating system and to manage information in a transparent and open manner.
The global Phase 3 clinical trial of AR1001, a multi-modal oral Alzheimer's disease treatment, is currently underway with a target of 1,250 participants. The Phase 3 trial in the United States began in late 2022, and patient recruitment and treatment are progressing smoothly at over 60 major clinical centers in the United States. In Korea, AR1001 has been designated as the first public-benefit clinical trial support target, and patient recruitment for the Phase 3 trial is currently underway through the National Clinical Trial Support Foundation portal under the Ministry of Health and Welfare. In China, the Phase 3 trial protocol has already been submitted to the National Medical Products Administration (NMPA), and approval is expected soon.
AriBio CEO Jeong Jae-jun said, "We expect patient recruitment to begin as early as February in the UK and March in the EU. Now that the application for multi-national global Phase 3 clinical trials by continent has been completed, we will proceed with the clinical trials smoothly and quickly and produce clinical data under the best conditions.
