Brown algae in shallow sea just west of North Point Peninsula on San Salvador Island in the Bahamas.
China has approved its first homegrown Alzheimer’s treatment — a novel drug based on algae, and the first breakthrough since 2003 in a field that has frustrated scientists and drug companies for decades.
Oligomannate, which contains material from marine brown algae, received a conditional go-ahead to treat mild to moderate Alzheimer’s, China’s National Medical Products Administration said Saturday.
In Phase 3 clinical trials it showed statistically significant cognitive improvements in patients with the disease in mild to moderate severity.
The drug is the result of years of research from a Chinese team led by Geng Meiyu at the Chinese Academy of Sciences’ Shanghai Institute of Materia Medica and Shanghai Green Valley Pharmaceuticals.
It’s the first new treatment for the disease to win regulatory approval in more than a decade and a half.
Long ago, the team noticed that individuals who consumed high amounts of seaweed had lower rates of Alzheimer’s, the most common type of dementia. This led to years of experimentation that eventually resulted in the trials with Oligomannate, also called GV-971.
“I have been doing research on Alzheimer’s disease for 50 years, participated in multiple global multicenter studies of multiple drugs, and have never found a satisfactory treatment for Alzheimer’s disease,” said Zhang Zhenxin, a medical doctor and principal investigator of the trial and professor of neurology at Peking Union Medical College Hospital in Beijing. ”The result of the nine-month trial of Oligomannate is exciting. We finally see hope and dawn. I am sincerely happy for the patients and their families.”
The drug is expected to be available in China within the next two months, Green Valley said, adding that it will apply for marketing authorization in several countries following the China launch. Once on the market, it will conduct global clinical trials in the U.S., Europe and elsewhere in Asia, it said.
Unlike previous medicines that directly targeted the brain, Oligomannate aims to alter the environment of a patient’s gut — which in turn reduces inflammation in the brain.
Those previous attempts, many of which failed, include billions of dollars spent by pharmaceutical giants including Pfizer Inc. PFE, -0.26% , Merck & Co. MRK, -0.34% and Johnson & Johnson JNJ, -0.13% .
Several other Chinese companies are also working on Alzheimer’s treatments. Jiangsu Lanfeng Biochemical Co. 002513, +9.98% and Zhejiang Jingxin Pharmaceutical Co. 002067, +0.33% — both listed on the Shenzhen Stock Exchange — saw their share prices rise the 10% maximum on Monday. Green Valley is currently unlisted.
In 2003, Allergan’s AGN, +0.65% Forest Labs was the last company to successfully develop an Alzheimer’s drug, called Namenda, but the company faced an antitrust lawsuit when it forced patients to switch to an extended-release form of the drug. Other companies have faced their own problems — whether regulatory impediments, price overruns or poor therapeutic results.
“This is the first new therapy for Alzheimer’s disease approved in many years, and we applaud this innovation,” said Jeffrey Cummings, vice chairman for research in the Department of Brain Health at the University of Nevada, Las Vegas. (Cummings is also the founding director of the Center for Neurodegeneration and Translational Neuroscience at the Cleveland Clinic and a scientific adviser to Green Valley.)
The drug will face ongoing scrutiny, however. China’s green light represents only a conditional approval, and ongoing studies are required to ensure that the drug’s safety and efficacy meet regulators’ satisfaction.
Dementia affects about 50 million people globally, with Alzheimer’s accounting for two-thirds of cases, according to the U.S.-based Alzheimer’s Association. The financial burden is estimated at more than $600 billion per year.
Tanner Brown is a contributor to MarketWatch and Barron’s and producer of the Caixin-Sinica Business Brief podcast.