This controversial, first-of-its-kind, algae-based drug for Alzheimer’s was approved in China. But citing financial concerns, the drugmaker is retiring it for good.
Green Valley Pharmaceuticals’ seaweed-based drug hit the market in China more than five years ago. But its run is coming to an end.
The drug, sodium oligomannate, was a first-of-its-kind microbiome-targeting treatment — and it appeared to slow cognitive decline in a Chinese Phase 3 trial. It received conditional approval in China in 2019, pending continuous clinical trials to test its safety. In April 2020, the U.S. Food and Drug Administration greenlit a much larger Phase 3 study to test the drug in upwards of 2,000 study participants across China, the United States, and Europe. But by spring of 2022, drugmaker Green Valley had canceled the global trials, citing “unexpected financial challenges related to the COVID-19 pandemic in China,” as former Green Valley scientific advisor Eric Reiman told media at the time. And this month, news broke that the company would stop producing the medication for good.
In China, companies typically apply to renew the license to market and sell a drug six months before this license expires. Green Valley declined to renew their license for sodium oligomannate, reportedly due to operational strain.
Also known as the “seaweed drug,” sodium oligomannate is derived from various types of brown algae. The concept: This biomatter provides nutritious food for the community of bacteria living in the gut. By targeting gut microbes, drug developers thought the drug could reduce inflammation in the body and the brain, and that this process would ease Alzheimer’s-related cognitive decline. In other words, the approach was like introducing more native flowers for pollinators in a forest: One small change might be able to make the whole ecosystem a little healthier.
It’s not the craziest idea: Mounting research has shown that treatments for Alzheimer’s and cognitive impairment could stem from the gut: Some studies have found that changing the bacteria living in the gut can impact cognition, and, in some mice studies, potentially even reverse some cognitive aging. But, even after that promising initial Phase 3 trial in China, some experts remained wholly unimpressed, publishing critical comments about the data. “The company provides curious and tenuous results for its efficacy, even if we accept the outcomes at face value,” wrote Lon Schneider at the University of Southern California Keck School of Medicine.
The drug company itself also came under fire at the time, with experts recalling the 2008 dispute in which Green Valley ran into regulatory trouble for marketing a fungus-based treatment for cancer without sufficient evidence, resulting in lawsuits and some bad press in China.
Yi Rao, a neurobiologist and president of Capital Medical University in Beijing who published criticism in Cell Research questioning the underlying mechanism based on previous studies of the drug, went so far as to tell Being Patient at the time of the drug’s China approval that suspicions were swirling that the drug was a “fraud.”
All this said, scientists are continuing to research the gut-brain axis and the diet-inflammation-brain health connection, as well as to probe findings that the make-up of bacteria in the gut is different in people with Alzheimer’s than in neurologically healthy people. It may be the first Alzheimer’s microbiome drug to have hit the market — if only temporarily — but it may not be the last to make it this far.
