Aribio 'AR1001' Recruiting Participants for Phase 3 in Korea... Utilizing National Clinical Trial Support Foundation Platform

Aribio announced on the 29th that it will begin recruiting participants for the domestic Phase 3 clinical trial of 'AR1001,' an oral treatment for Alzheimer's disease dementia under development.

This clinical trial, which evaluates the safety and efficacy of AR1001 in patients aged 55 to 90 with early Alzheimer's disease, is part of the global Phase 3 clinical trial 'Polaris-AD,' involving a total of 1,250 participants across Korea, the United States, China, and Europe. The domestic recruitment target is 150 to 200 patients. AR1001, developed by Aribio, is explained to have effects of inhibiting dementia progression and improving patients' memory and cognitive function through phosphodiesterase (PDE) 5 inhibitory action.

The domestic Phase 3 clinical trial will be conducted through the public platform of the Korea National Enterprise for Clinical Trials (KoNECT). For this trial, KoNECT has established a dedicated AR1001 clinical trial page on the Korea Clinical Trials Participation Portal, where information search and participation application are possible. Patients who wish to participate or are interested can apply through the dedicated 'Alzheimer's Disease AR1001 Clinical Trial Participation' page on the Korea Clinical Trials Participation Portal.

Applicants will receive notification messages, and after completing and submitting a screening questionnaire, candidates will be selected based on the responses. Once the clinical trial sites are confirmed, candidates will be further guided via notification messages to select a clinical trial site.

This is described as the world's first model to support clinical trials for Alzheimer's disease dementia treatments through a public platform. During the COVID-19 pandemic, KoNECT operated the 'COVID-19 Clinical Trial Portal,' recruiting participants for domestic COVID-19 vaccine and treatment development clinical trials and linking them to clinical trial sites. Based on this experience, Aribio’s AR1001 Phase 3 clinical trial, which has entered Phase 3 in the United States, was selected as the first public interest clinical trial support project in January, preparing support for the domestic trial.

Park In-seok, Director of KoNECT, stated, "Through the Korea Clinical Trials Participation Portal, which ensures publicness, reliability, and transparency, we will provide easy-to-understand information about the clinical trial and convenient opportunities for participation to prospective participants," adding that "this will contribute to enhancing public access to new drugs and the development of new drugs."