Posted on Jul 13, 2020, 3 p.m.
Over the past decades over 190 experimental therapies have either been abandoned or failed in clinical trials, representing decades of research and billions of dollars invested in searching for a cure to combat Alzheimer’s disease.
A drugmaker in Shanghai has developed an experimental seaweed drug that may be offering a glimmer of hope. Green Valley Pharmaceuticals’ experimental drug candidate oligomannate is the first new Alzheimer’s drug to emerge in close to 17 years, and it has received conditional approval in China and it was available to patients there by the end of 2019. In acknowledgment of urgency and in a bid of confidence the FDA have given the company approval to move their drug candidate straight into late stage clinical trials in America.
While the majority of drugmakers are focusing much of their efforts on beta amyloid which are a key biomarker of this disease, this experimental drug is taking a different approach by attempting to reduce inflammation in the brain by way of altering the gut microbiome.
This global trial will be enrolling more than 2,000 patients who are experiencing mild to moderate Alzheimer’s disease across American, Europe, and Asia, according to Bloomberg. But it is not known how many of the patients will be in America, and clearance from the other countries is still going through the approval process. During the year-long trial phase some participants will be given a placebo while others are given oligomannate, and the researchers will be blind as to what patients are receiving; and during an additional 6 month phase all of the patients will be receiving the drug.
Despite the slowdowns that are occurring delaying much research and trial dates due to the recent outbreak, Green Valley is cautiously optimistic but still is aiming to have an FDA approved drug to be available on the market by 2025 if all goes well. These American trials are just the first step in a global multi-center Phase III trial effort, which “won’t be a success until the drug gets approved,” said Li Jinhe, who is the company’s vice president of global operations.
“Good results coming out of the drug trials in China have boosted our confidence,” said Li. ‘We believe it will eventually be launched globally to benefit more patients.”
FDA approval of an available drug can not come fast enough to the global estimate of some 44 million people that are affected by Alzheimer’s disease, as well as their caretakers and loved ones that are anxiously awaiting for positive news of a cure for this currently incurable neurodegenerative disorder.
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