Chinese Alzheimer's Drug Gets U.S. Approval for Stateside Trial

Chinese drugmaker Shanghai Green Valley Pharmaceutical has received approval from the U.S. Food and Drug Administration (FDA) to begin clinical trials in the United States for its experimental Alzheimer's drug oligomannate, reports Bloomberg . The company reportedly aims to enroll more than 2,000 participants with mild-to-moderate Alzheimer's across North America, Europe, and Asia — as well as file for FDA approval to sell the drug by 2025 after the trial ends. The start of the trial may be pushed back by the coronavirus pandemic, but Shanghai Green Valley's Li Jinhe doubts that this will affect its long-term timeline. The oligomannate trial will last a year, during which neither investigators nor participants will know who has been administered the drug or who has received a placebo, in order to avoid bias when interpreting results. Oligomannate is designed to readjust the human body's gut microbiome, which Green Valley says ultimately reduces neuron inflammation in the brain and slows the progression of Alzheimer's. "Good results coming out of the drug trials in China have boosted our confidence," said Li. "We believe it will eventually be launched globally to benefit more patients."