On Saturday (November 2), Chinese regulators approved a drug to treat Alzheimer’s disease—the first new treatment to enter the global market in 17 years. Shanghai Green Valley Pharmaceuticals’s oligomannate boosted cognitive function among clinical trial participants who had mild to moderate Alzheimer’s as early as a month after taking the drug, compared with those who took a placebo.
Although investigators have yet to show how the drug works in people, scientists at the company reported in September that oligomannate, a mix of oligosaccharides derived from seaweed, adjusts the microbiome in mice such that inflammation-causing amino acids from gut bacteria no longer irritate the brain.
“These results advance our understanding of the mechanisms that play a role in Alzheimer’s disease and imply that the gut microbiome is a valid target for the development of therapies,” neurologist Philip Scheltens, who advises Green Valley and heads the Alzheimer Center Amsterdam, says in a company statement, according to CNN.
CNN adds that the approval of oligomannate is conditional, and the drug will be monitored for safety issues and could be pulled if any arise.
Oligomannate’s approval comes on the heels of a string of disappointing clinical results for other Alzheimer’s interventions that target amyloid-β protein, although the drugmaker Biogen announced in October that it would still pursue US approval of one of them, aducanumab.
FiercePharma notes some of the limitations of oligomannate’s clinical data, such as the lack of significant improvement on three standard measures of therapeutic efficacy and no measures of Alzheimer’s-related biomarkers, such as tau or amyloid-β accumulation.
“We’re always excited to have a new potential treatment,” Joy Snider, a neurologist at Washington University in St. Louis, tells STAT, “but I certainly would not prescribe it to my patients based on a single study or another country’s approval until we know more about it.”
Kerry Grens is a senior editor and the news director of The Scientist. Email her at email@example.com.