FDA clears US trials of Green Valley's Alzheimer's drug

China’s Shanghai Green Valley Pharmaceuticals has clearance to begin a late stage clinical trial to support a US filing of its potential Alzheimer’s drug.

The rest of the pharma industry has been struggling for almost two decades to find new therapies that help to slow or reverse the onset of Alzheimer’s.

But in November Green Valley became the first pharma since 2003 to get a novel drug approved by a major regulator in Alzheimer’s, after China’s National Medical Products Administration (NMPA) gave oligomannate the nod.

Studies in China showed oligomannate, codenamed GV-971, improved cognitive function in mild to moderate Alzheimer’s and the pharma has permission from the FDA to begin a large multi-centre phase 3 study to test whether results can be replicated in patients outside China. 

However we will have to wait until 2024 for the trial to be completed, and if things go well a filing is expected in 2025. 

Green Valley is working with contract research giant IQVIA to manage the phase 3 study, which will recruit more than 2,000 patients with mild to moderate disease. 

The study will involve a 12-month double-blind treatment period and six-month open-label period and will be conducted at 200 sites in North America, Europe, and Asia-Pacific regions including China. 

Professor Jeffrey Cummings, a leading Alzheimer’s expert from the Neurological Institute, Cleveland Clinic is leading the clinical trial design, chairing a scientific committee including principal investigators Martin Farlow, Roy Jones and Bruno Vellas. 

The leading principal investigators in China are Professor Jia Jianping of Xuanwu Hospital of Capital Medical University and Professor Xiao Shifu of Shanghai Mental Health Center. 

Earlier this month Biogen announced that it has put back a filing of its potential Alzheimer’s drug aducanumab from the first half of this year until the third quarter. 

Biogen had axed two phase 3 trials of aducanumab last year, but late last year said it would file after all after noticing that patients treated with a higher dose had shown a significant decrease in clinical decline. 

While aducanumab is an antibody targeting amyloid plaques that build up in the brains of people affected by Alzheimer’s, oligomannate is a mixture of oligosaccharides from marine brown algae that rebalance gastrointestinal microbes to inhibit the abnormal increase of certain metabolites. 

This reduces peripheral inflammation, deposition of plaques and abnormalities in Tau proteins also associated with Alzheimer’s, the company said. 

A growing body of evidence reveals that gut microbiota is highly correlated with the incidence of Parkinson's disease, depression, autism and other central nervous system diseases, Green Valley said.