AriBio, primarily known for its work to develop an oral Alzheimer's disease treatment candidate, has been penalized for the sale of cosmetics containing ingredients that are not permitted for use.
The Ministry of Food and Drug Safety issued the penalty last Thursday, mandating a three-month suspension of AriBio's cosmetic sales operations. This suspension is effective from Feb. 1 to April 30.
However, the ministry did not disclose which product contained the prohibited ingredient.
AriBio is working on AR1001, which is the first orally administered multi-mechanism Alzheimer's disease treatment developed by a Korean biotech company.
The company is currently conducting a multi-country phase 3 trial (project name Polaris-AD) that aims to enroll 1,250 patients, including 600 patients in the U.S., 400 in Europe, 150 in Korea, and 100 in China.
The trial began patient dosing in Dec. 2022 following approval from the U.S. FDA.
In Korea, patient recruitment is also taking place through the National Clinical Trial Support Foundation.
AriBio plans to sequentially conduct phase 3 trials in China and eight European countries.
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