Last year, a Shanghai-based company won the first new approval for an Alzheimer’s drug in 17 years. Now Green Valley Pharmaceutical Co., whose treatment was approved by Chinese regulators, is setting its sights on the U.S. and EU market as it prepares for clinical trials that could pave the way for an FDA nod.
The drug, Oligomannate, which is based on seaweed, isn’t without its doubters, however. Unlike most drugmakers who have worked on targeting beta amyloid, which can cause plaques in the brain, Green Valley developed its drug to impact microbiome in the gut and in turn, reduce brain inflammation. The company reportedly got the idea after observing that those who regularly ate seaweed contracted Alzheimer’s at a lower rate.
Others have also criticized the speed at which the drug was studied in China and the lack of details produced from its clinical trials.
Green Valley isn’t stepping off the gas though to win wider approval. The company is reportedly planning to recruit over 2,000 patients for trials in the U.S., EU and Asia Pacific. It plans to file for FDA approval for a trial in February and is gunning for Fast Track designation.
Read the full Bloomberg report.
