AriBio announced on the 26th that its trial plan for the global phase 3 POLARIS-AD of the oral Alzheimer’s disease treatment, AR1001, has been approved by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).
With this authorization, AriBio has now expanded the number of countries conducting the global phase 3 of AR1001 to three, following the US and Korea. Clinical trials in the UK have been scheduled to start at the end of the first quarter of this year.
The global phase 3 POLARIS-AD of AR1001 targets a total of 1,250 people. By country and region, there are approximately 600 in the US, 150 in Korea, 100 in China, and 400 in the UK and seven countries in the European Union.
AriBio has submitted phase 3 trial plans in China and to seven major countries of the European Union. The trial will evaluate the efficacy and safety of AR1001 for 52 weeks in patients with early Alzheimer’s disease.
The main evaluation indicators that have been approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are CDR-SB (Clinical Dementia Rating-Sum of Boxes), ADAS-Cog13 (Alzheimer’s Disease Assessment Scale-Cognitive Subscale), A-iADL (Amsterdam-IADL Questionnaire), GDS (Geriatric Depression Scale), etc.
CEO of AriBio Matthew Choung said, “The UK MHRA’s phase 3 approval is an important achievement as patients in Europe can now begin taking AR1001.” He added, “AriBio’s POLARIS-AD is truly a global clinical trial targeting the world that brings us a final step closer to treating Alzheimer’s Disease.”
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