loomberg News reports that a newly approved Chinese drug for Alzheimer’s will start clinical trials in the U.S. and Europe this year as the country’s first novel therapy for the incurable disease seeks global legitimacy.
Shanghai Green Valley Pharmaceutical Co. (Green Valley) plans to recruit around 2,000 patients with mild-to-moderate Alzheimer’s for trials at 200 sites across North America, Europe and Asia Pacific for 18 months, the company’s Vice President Li Jinhe said.
The drug, an extract of brown algae called Oligomannate, was granted conditional approval in China last month. It comes in a 150mg capsule and went on sale in the country on Dec. 29. Patients will need to take three capsules twice a day, according to the drug’s package insert. A week’s treatment costs 895 yuan (US$128).
Green Valley announced these plans in a press conference in Beijing nearly two months after making global headlines for saying it got approval from China’s regulator for the first new Alzheimer’s drug in 17 years.
The company said it plans to invest $3 billion in the next 10 years for investigations and global trials to understand its working mechanism and expand its use in treating diseases such as Parkinson’s and vascular dementia.
Green Valley plans to file an application for clinical trials with the U.S. Food and Drug Administration in February 2020. It also wants to secure the Fast Track designation, said Green Valley’s Li. This tag helps expedite regulatory review of drugs that treat serious conditions or fill an unmet medical need. The company is also exploring partnerships with global drug makers to speed up clinical trials and help launch the product outside China, Li said.
The Green Valley therapy works differently from the approach taken on Alzheimer’s by western drug developers. Its Oligomannate drug – the name refers to a type of sugar extracted from brown seaweed – is unusual in that it does not target beta amyloid, a protein that forms clumps of plaque in the brain, clogging it in patients with Alzheimer’s.
Oligomannate instead seeks to readjust microbiome in the gut, which ultimately leads to reduced neuron inflammation in the brain and slows the progression of the disease, according to the company.
In Chinese trials, the drug had statistically improved cognitive function in patients suffering from mild-to-moderate Alzheimer’s as early as week four, Green Valley said in a November statement. Its success, however, has been met with skepticism from Alzheimer’s researchers, who say that details are scant on its clinical trials in China.
“Doubts always accompany scientific discovery,” says Geng Meiyu, a researcher with Shanghai Institute of Materia Medica who led the discovery and research of the drug, adding that Green Valley will continue to look into the drug’s working mechanism among humans through further studies and scientific collaboration. “This is just the first step of a long march,” said Geng.