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A newly approved Chinese drug for Alzheimer's will start clinical trials in the US and Europe next year as the country's first novel therapy for the incurable disease seeks global legitimacy.
Shanghai Green Valley Pharmaceutical plans to recruit around 2 046 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 on Sunday.
The drug, called Oligomannate, was granted conditional approval in China last month. It comes in a 150mg capsule and went on sale in the country on December 29. Patients will need take three capsules twice a day, according to the drug's package insert. A week's treatment costs 895 yuan ($128).
Green Valley announced these plans in a press conference in Beijing on Sunday, 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 neuro-degenerative disease has baffled global drug makers, who have invested billions of dollars into more than 190 experimental drugs with little to show for it.
The Shanghai-based firm, unknown outside of China, is facing scepticism that it could have so quickly achieved something that's eluded western pharmaceutical giants for decades.
"It's totally understandable for our drug to be questioned," said Green Valley Chairman Lyu Songtao. "We are confident because we see clear benefits from patients in the clinical trials."
The conditional approval requires the drugmaker to conduct further studies on how the drug works and its long-term safety and efficacy. The company also said it plans to invest $3bn in the next 10 years for such investigations - including on global trials - to understand its working mechanism and expand its use in treating diseases such as Parkinson’s and vascular dementia.
Rapid approval
In its mission to get its vast patient pool access to top-quality health care, China's drug regulator has been granting rapid approval to novel, experimental treatments, sometimes faster than its counterparts in the US and Europe. Beijing is also nurturing its biotech sector in China's quest to become a global leader in medical and scientific research.
Alzheimer's affects 10 million people in China and 5.8 million in the US. Researchers estimate there are 50 million people worldwide living with dementia, with Alzheimer's the cause in as many as 70% of cases - implying a big addressable market for Green Valley if it manages to take the drug global.
Drugs that halt the debilitating disease could be a market worth as much as $30bn in the US alone, according to an estimate by analysts at Sanford C Bernstein.
Global pharmaceutical giants including AstraZeneca Plc, Eli Lilly and Roche Holding have invested billions of dollars over the years but failed to develop therapies for this disease. In October, Biogen said it plans to resume abandoned studies of its experimental therapy after new analysis of data showed promising results.
Green Valley plans to file an application for clinical trials with the US 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 drugmakers to speed up clinical trials and help launch the product outside China, Li said.
Brown seaweed
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.
After years of failure, a backlash has grown over drugmakers' fixation on beta amyloid as the key to a cure, but major pharmaceutical companies have yet to seriously explore an alternative.
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 scepticism from Alzheimer's researchers, who say that details are scant on its clinical trials in China.
In a story carried by Science magazine shortly after the drug was approved in China, Mark Oremus, an epidemiologist at the University of Waterloo in Canada, called the 36-week phase III trial by Green Valley as "far too short to evaluate the medium- to long-term effects." Also, it didn't compare the drug with other existing medications, Oremus said.
Local media reported that some industry researchers are calling for more evidence to prove that altering microbiome in the stomach can help slow cognitive impairment.
"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.
