Chinese Alzheimer’s drug gets FDA approval for global clinical trials
GV-971, a native drug for the treatment of Alzheimer’s disease.
A new drug developed by Chinese researchers to treat Alzheimer’s disease has been approved by the US Food and Drug Administration (FDA) for clinical trials in overseas patients.
Green Valley Pharmaceuticals, one of the drug’s co-developers, posted a notice on its website on Sunday that the FDA authorized the drug for use in humans. The Shanghai Institute of Pharmaceutical Research of the Chinese Academy of Sciences confirmed this in a statement.
The oral drug GV-971 is a 22-year study led by researchers at the Institute, Ocean University of China and Green Valley. According to an article published in the international journal Cell Research in September 2019, the drug derived from brown algae works by modifying gut bacteria to ultimately reduce brain inflammation in mice genetically modified to suffer from the disease.
China’s State Drug Administration approved its launch last November, saying the drug “can improve cognition in patients with mild to moderate Alzheimer’s disease (AD)”.
The statement said, “With clinical data on the Chinese patent, Green Valley applied for and received approval from the FDA for an international multicenter trial, which shortened the drug marketing process and brought new hope to more overseas AD patients.”
Green Valley said the drug will be tested in 200 clinical centers in North America, the European Union, Eastern Europe, Asia-Pacific and elsewhere, adding that the entire clinical study will skip phase 1, phase 2 and go straight to phase 2. 3 trials and final testing before entering the market.
According to Bloomberg, the FDA’s approval highlights the urgent need for Alzheimer’s disease and U.S. regulators’ satisfaction with data from clinical trial records in China.
The company said it plans to complete global clinical trials in 2024 and submit new drug applications in 2025.
A caregiver at the private institution Beijing Intensive Nursing Home cares for an Alzheimer’s patient in March 2011. [Feng Yongbin/China Daily] Green Valley CEO Jack Ren said in a media interview that clinical trials will start later than planned due to the popularity of COVID-19, but the impact will not be significant in the long run.
AD is an irreversible progressive brain disease that gradually destroys memory, thinking and the ability to perform simple tasks.
According to the World Health Organization, at least 50 million people worldwide suffer from dementia, and AD is the underlying cause of 60 to 70 percent of cases.
Despite significant efforts in the treatment of AD, global drugmakers have witnessed consistent failure of 320 drug candidates in late-stage clinical trials over the past two decades.
GV-971 is the first new drug with the potential to treat AD within 17 years