Including the United States, Korea, the UK, Germany, Czech Republic, etc.
“Goal to announce top-line in 2026 and apply for new drug approval”,
, “AriBio’s oral Alzheimer’s treatment ‘AR1001’ being developed has received approval for phase 3 clinical trials in 11 countries including China.”,
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, ‘AriBio announced on the 14th that it has received official approval from the Center for Drug Evaluation (CDE) under the National Medical Products Administration of China for the phase 3 clinical trial plan (IND) of AR1001.’,
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, ‘With this approval from China, the global phase 3 clinical trial (Polaris-AD) for AR1001 will proceed as planned, targeting a total of 1,150 participants at over 200 clinical centers in 11 countries. The 11 countries include the United States where the first patient dosing commenced, as well as Korea, the UK, Germany, France, Spain, Italy, Denmark, the Netherlands, Czech Republic, and China. AriBio’s clinical team in Korea and its research team in San Diego, USA, are directly managing the overall global clinical trial.’,
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, ‘The phase 3 trial in China for AR1001 will involve around 150 patients at 20 clinical centers, applying the same criteria as the countries already conducting trials. The study will evaluate the cognitive function improvement and the delay in Alzheimer’s disease progression of AR1001 through a 52-week double-blind, randomized, placebo-controlled, multicenter phase 3 trial in early Alzheimer’s disease patients.’,
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, ‘Key evaluation indicators include Clinical Dementia Rating-Sum of Boxes (CDR-SB), Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13), Amsterdam-Instrumental Activities of Daily Living Scale (A-iADL-S-QV), Geriatric Depression Scale (GDS), Mini-Mental State Examination (MMSE), changes in cerebrospinal fluid (CSF) and plasma biomarkers, and more.’,
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, ‘As each country completes the approval process for the phase 3 trial plan of AR1001, AriBio expects a seamless progress towards the announcement of top-line data in 2026 and subsequent new drug application (NDA).’,
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, ‘Jung Jae-joon, CEO of AriBio, stated, “With the global demand for dementia response, we are garnering support and attention for the phase 3 clinical trials of AR1001, a multi-target oral therapy” adding “Being the first among all biopharmaceutical companies in Korea to directly manage a large-scale global phase 3 trial is a source of pride and sense of duty for AriBio, and we will do our best for the success of the new drug.”‘, ‘article_split’,
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