Phase 3 underway in 7 countries, including Germany and France
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[서울=뉴시스]Reporter Song Yeon-ju = Bio company Aribio announced on the 29th that it received approval from the European Union (EMA) to conduct a global phase 3 clinical trial (Polaris-AD) for the oral Alzheimer’s disease treatment candidate ‘AR1001’.
This European phase 3 clinical trial was simultaneously approved in seven European countries, including Germany, France, Spain, Italy, Denmark, the Netherlands, and the Czech Republic, in accordance with the clinical trial regulations newly established by the European Medicines Agency (EMA) in 2022. Including the UK (MHRA), where phase 3 has already begun, the final clinical trial will be conducted with 300 patients at 70 clinical centers in 8 European countries.
POLARIS-AD, a phase 3 study, will be conducted with 1,150 patients at over 200 clinical centers in 11 countries, including the US, UK, Europe, and Korea. This is a 52-week study to evaluate the efficacy and safety of AR1001 in patients with early-stage Alzheimer’s disease. Through various cognitive and functional evaluations, we plan to evaluate the efficacy and safety of AR1001 in improving cognitive function and slowing the progression of Alzheimer’s disease.
Aribio CEO Jeong Jae-jun said, “We expect that the expansion of clinical trials in Europe, a major axis of the global market, along with the United States, where phase 3 is already in progress, will have a positive effect on global sales rights negotiations.”
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