Alzheimer's drug in China shows promise

A Chinese pharmaceutical company has surged ahead of the US and Europe to develop and approve an Alzheimer's drug that could help the cognitive functions of patients with a mild form of the disease.

The drug Oligomannate, a product of Shanghai-based Green Valley Pharmaceuticals, was given conditional approval on Saturday by China's National Medical Products Administration.

Research into the drug's efficacy is still needed, and the drug could be withdrawn if safety issues arise, the organization said.

The Chinese breakthrough comes after major US pharmaceutical companies Johnson & Johnson, Merck, Pfizer and Eli Lilly recently abandoned projects to develop a drug for Alzheimer's over safety issues. Over nearly 20 years, there have been 400 clinical trials and billions of dollars spent trying to find a cure.

The new drug will be the first approved in 17 years to treat the degenerative disease. Green Valley said Oligomannate would be released in China by the end of this year. The company will then carry out phase three trials abroad in 2020 and later seek approval to market the drug in the US and Europe.

Maria C. Carrillo, chief science officer at the US-based Alzheimer's Association, told China Daily in a statement: "On behalf of the tens of millions worldwide living with Alzheimer's disease, the Alzheimer's Association acknowledges and welcomes the announcement that China's National Medical Products Administration conditionally approved the seaweed-based drug Oligomannate for mild to moderate Alzheimer's dementia."

Oligomannate, taken orally, is made from extracts of brown algae as raw material and works by suppressing certain bacteria in the gut that cause neural degeneration and inflammation in the brain. It was jointly developed by the Chinese Academy of Sciences' Shanghai Institute of Materia Medica, Green Valley, and Ocean University.

During trials, it was tested on 818 people, but doctors warn it may not help patients whose brains have degenerated beyond repair, or who wander or need help using the bathroom or bathing.

"Trial results demonstrated that Oligomannate statistically improved cognitive function in mild-to-moderate Alzheimer's patients as early as week four, and the benefit was sustained at each follow-up assessment visit," Green Valley Pharmaceuticals said in a statement.

Alzheimer's disease starts with memory loss and affects cognitive ability. To date, there is no cure. Those age 65 and over are at particular risk, but around 200,000 people under 65 have the disease.

In China, 9.5 million people have Alzheimer's, amid a rapidly aging population. In the US, more than 5.8 million live with it, according to the Alzheimer's Association. It is the country's sixth-leading cause of death among those age 65 and older. The total number of people affected by dementia worldwide is 50 million, and Alzheimer's accounts for 60 to 80 percent of those cases, according to the World Health Organization.

Carrillo, of the Alzheimer's Association, added that the association "is currently investing in more than 500 best-of-field research projects in 27 countries. In addition to funding important research, the Alzheimer's Association actively brings government, academia, companies and philanthropy together to accelerate science, because we know that collaboration is key to accelerating research."

In August, Beijing overhauled its drug laws by allowing conditional approval for some medicines with "predictable" clinical value for life-threatening diseases where treatment was not available, Reuters reported.

"The result of the nine-month trial of Oligomannate is exciting," Professor Zhang Zhenxin, a leading principal investigator of the phase three trial of Oligomannate and professor of neurology at Peking Union Medical College Hospital in Beijing, told The Pharma Letter, a news source for the pharmaceutical and biotechnology industries.

Finding a cure for Alzheimer's has been a costly road with many failures. But last month, Biogen, based in Cambridge, Massachusetts, said that next year it would seek approval from the US Food and Drug Administration to market its drug Aducanumab, which it said could help slow the effects of the disease.

Hunter K. Anstine, chief development officer for the Alzheimer's Research Foundation, said Alzheimer's researchers worldwide are doing crucial work that must continue despite any previous failures.

"A cure is possible," Anstine said. "We just need to put a lot of resources into it."