China has given the green light to a drug for the treatment of Alzheimer’s disease, the first with the potential to address cognitive impairment in nearly two decades without novelty. In addition, it is striking that this drug has its origin in marine algae and that it has resulted in the drug called Oligomannate, which is indicated for the treatment of mild to moderate forms, according to a statement from the drug safety agency of China.
This approval is subject to strict supervision, which means that although it may be available during additional clinical trials, as a pharmacovigilance, it will be supervised and could be withdrawn if a safety issue arises.
Why seaweed as an active ingredient?
Two months ago, the team led by Geng Meiyu at the Shanghai Medical Matter Institute of the Chinese Academy of Sciences said they were inspired to look for algae because of the relatively low incidence of Alzheimer’s among people who consume it regularly.
In an article in the journal Cell Research, Geng’s team described how a sugar contained in algae suppresses certain bacteria contained in the intestine that can cause neural degeneration and brain inflammation, leading to Alzheimer’s disease.
This mechanism was confirmed during a clinical trial conducted by Green Valley, a Shanghai-based pharmaceutical company that will be responsible for bringing the new drug to market. Good news for society and those affected, as Johnson & Johnson, Merck, Pfizer and Eli Lilly have abandoned projects to develop an Alzheimer’s drug after unsatisfactory clinical data.
How did they come up with positive results?
Conducted on 818 patients, a clinical trial found that Oligomannate, which is derived from brown algae, has the ability to statistically improve cognitive function among people with Alzheimer’s in as little as four weeks, according to a Green Valley news release.
“These results advance our understanding of the mechanisms that play a role in Alzheimer’s disease and imply that the intestinal microbiome is a valid target for the development of therapies,” says neurologist Philip Scheltens, who advises Green Valley and runs the Alzheimer’s Center in Amsterdam, in a statement.
Vincent Mok, who heads the neurology division at the Chinese University of Hong Kong, says the new drug has shown “encouraging results” compared to acetylcholinesterase inhibitors, the existing treatment for mild to severe Alzheimer’s disease. “It is equally effective but has fewer side effects,” he told CNN. “It will also open up new avenues for Alzheimer’s research, focusing on the intestinal microbiome.
The mechanisms of the new drug are not yet known for sure, so Mok says it should also be investigated to see if it would have a protective effect and possibly slow the progression of the disease in patients who have not yet developed strong symptoms of dementia.
Small steps that invite hope
The company has noted that Oligomannate will be available in China “very soon”, and is currently seeking approval to market it abroad, with plans to launch phase III clinical trials in the United States and Europe in early 2020.
According to the World Health Organization, Alzheimer’s disease, which begins with memory loss and increases to severe brain damage, is believed to cause 60% to 70% of reported dementia cases worldwide. Dementia affects about 50 million people worldwide, including 9.5 million people in mainland China, Hong Kong and Taiwan.