Hope and skepticism
Alzheimer's specialists welcome Chinese drug market entry with cautious optimism
Marina Astvatsaturyan, Echo of Moscow
A plant-based drug developed by a Chinese biotech startup improves the cognitive functions of patients with Alzheimer's disease by changing their intestinal microbiome, reports ScienceMag.
In studies on mice, the results of which were published earlier this year, this remedy reduced inflammation in the brain of rodents in which a pathology similar to Alzheimer's disease was modeled using genetic engineering.
According to the creators of the drug, in phase III clinical trials, about 800 people "showed a significant and consistent improvement in cognitive activity" compared to the control group.
Although these data have not yet been published in the scientific press, they served as a sufficient reason for the relevant Chinese regulatory agency (National Medical Products Administration) to give permission for the commercialization of a new drug, so far called GV-971, provided that additional information is collected indicating its safety and effectiveness.
GV-971 is the first drug for the treatment of Alzheimer's disease approved anywhere in the world since 2003. Among the neuroscientists not associated with the Shanghai company that created it Green Valley Pharmaceutical, the news about the drug has generated both hope and skepticism. "I think it's wonderful, and if it's true that the effect is achieved through the microbiome, it's fantastic," says Sangram Sisodia, a neuroscientist at the University of Chicago in Illinois, who studies the effect of the microbiome on the development of Alzheimer's disease in mice. But he would like more evidence of safety, and other experts are not at all convinced that some of the improvements in alzheimer's patients noted in cognitive tests are clinically significant.
Green Valley presented its clinical trial results at several conferences and in press releases issued jointly with the institutes where the active substance was created, but not in peer-reviewed scientific articles. The active component of the drug is sodium oligomannurate, isolated from brown algae.
The results of his research on mice, published in the September issue of the journal Cell Research, suggest that as the disease progresses, an imbalance of the intestinal microbiota causes the production of immune cells that penetrate into the brain and exacerbate neuroinflammation associated with the development of Alzheimer's disease. GV-971 remodels the intestinal microbiome, reducing the accumulation of such cells.
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