On 10 October, AriBio - a clinical-stage biopharmaceutical company developing innovative drugs for specific diseases including neurodegenerative and infectious diseases – announced that it has filed an investigational new drug (IND) application with the US Food and Drug Administration (FDA) for a phase III clinical trial of its investigational dementia drug AR1001. The company plans to start its Phase III study evaluating the efficacy and safety of AR1001 for the treatment of people with early Alzheimer’s disease (AD) by the end of this year. The Phase III trial will be conducted by dividing 1,600 participants into two groups. The first Phase III trial will be conducted in the US and the second one will be conducted globally in Europe and Korea. Participants will receive oral tablets daily (either AR1001 or placebo) for 52 weeks. After the 52-week administration, participants will have the opportunity to be enrolled in an extension study where all participants will receive AR1001. http://www.koreabiomed.com/news/articleView.html?idxno=14782
AriBio has applied to FDA for its Phase III clinical trial of AR1001
10/10/2022