U.S. Clinical Trials May Begin in 2020 on Oral Drug to Treat Mild to Moderate Alzheimer’s

WASHINGTON, DC (November 4, 2019) – George Vradenburg, chairman and co-founder of UsAgainstAlzheimer’s, welcomed the announcement by Shanghai Green Valley Pharmaceuticals that Oligomannate had been approved by China's National Medical Products Administration as a new oral treatment for mild to moderate Alzheimer's disease based on its demonstration in clinical trials of improved cognition.

Green Valley said it will launch Oligomannate in China later in 2019 and that it plans to start phase 3 clinical trials in the U.S., Europe and Asia in early 2020. 

“China’s regulatory decision makes Oligomannate the first new drug approved anywhere in the world for treating Alzheimer's patients since 2003 and is hopeful news for people living with the disease, their caregivers and families,” Vradenburg said. Noting that the approval of Oligomannate is only for use in China, Vradenburg added, “We look forward to U.S. clinical trials into this new oral drug starting in 2020.

“The tide on Alzheimer’s drug therapies seems to be turning after years of setback and disappointment,” Vradenburg said. “The Chinese approval of Oligomannate for treatment of mild to moderate Alzheimer’s is the third encouraging sign recently of treatment breakthroughs. It follows the announcement last month that Biogen and Eisai intend to seek approval by the Food and Drug Administration in early 2020 of Aducanumab as a therapy for early Alzheimer’s and the announcement that Acadia Pharmaceuticals plans to submit pimavanserin for regulatory review for the treatment of dementia-related psychosis.”

According to Green Valley, Oligomannate works by modifying the regulation of the gut microbiata, a different method of action than that used in Aducanamab and pimavanserin.  

“This diversification in the methods of attack against Alzheimer’s is an important development,” Vradenburg said. “In the near future, we can look forward to an increasing array of innovative approaches — and combinations of approaches — to prevent and treat this disease. 2020 looks to be a turning point in the fight against Alzheimer’s. Hope and optimism are now the emotional currency in the Alzheimer’s field. It’s about time.”

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About UsAgainstAlzheimer’s (UsA2)

UsAgainstAlzheimer’s (UsA2) is a disruptive advocacy and research-focused organization that is pushing for expanding treatments and accelerating towards a cure for Alzheimer’s disease. UsA2’s transformative programming is laser-focused on proactive brain health across the lifespan and understanding what matters most across the lived experiences of those affected by Alzheimer’s in the service of preventing, treating and curing this disease.  We are working to ensure that all communities have their voices heard, and get a chance to be brain healthy from the earliest years while building resistance to and resilience against possible cognitive decline.