Chinese Alzheimer's drug to undergo global clinical trials
An innovative Chinese Alzheimer's drug extracted from brown algae is set to go through clinical trials on 2,000 patients overseas this year.
The orally administered drug GV-971 will be tested in 200 clinical centers in North America, the European Union, Eastern Europe, Asia Pacific and other places, according to Green Valley Pharmaceutical Company, one of the drug's co-developers.
China has already approved the drug.
Green Valley Pharmaceutical will complete the global clinical trials in 2024 and submit the New Drug Application to the US Food and Drug Administration and European Medicines Agency in 2025, Xinhua reported.
GV-971 was jointly developed by the Shanghai Institute of Materia Medica under the Chinese Academy of Sciences (CAS), Ocean University of China and Green Valley, after a 22-year study.
The results of the mechanism of action study were published in the international journal Cell Research in September 2019, saying that the drug works by modifying gut bacteria to ultimately reduce brain inflammation in mice that were genetically engineered to have the disease.
It was approved for marketing last November by China's National Medical Products Administration, which said the GV-971 "can improve cognition in patients with mild to moderate Alzheimer's disease (AD)."
According to researchers, apart from animal experiments, more than 1,100 Chinese Alzheimer's disease patients participated in clinical trials before the drug hit the market.
In the last test, a total of 818 participants from 34 leading hospitals in China took 450 mg GV-971 orally twice a day for a treatment period of nine months, which proved safe and effective in improving cognition.
"Because of its effectiveness on Chinese patients, we expect this drug to benefit more people in the rest of the world," said Lyu Songtao, Chairman of the Shanghai-based pharmaceutical company.IANS