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Shanghai Green Valley Pharmaceuticals gets approval of Oligomannate for mild to moderate Alzheimer's disease in China

Saturday 02 November 2019

On 2 November, Shanghai Green Valley Pharmaceuticals announced that it has received approval from China’s National Medical Products Administration (NMPA) for Oligomannate as a new oral treatment for mild to moderate Alzheimer's disease (AD). The new drug called Oligomannate or GV-971 is derived from marine brown algae, a seaweed, and works by restoring balance to the gut microbiota. It is the first new drug to receive regulatory approval globally in the world for Alzheimer’s disease since 2003 based on its demonstration to help improve cognitive function in people with mild to moderate AD.

Results of a 36-week multicenter, randomised and double-blind Phase III clinical trial showed that Oligomannate led to a statistical significant improvement in cognitive function in people with mild to moderate AD compared to placebo as early as week four and continued at each follow-up assessment visit. According to the company, Oligomannate and placebo groups showed a statistically significant difference of 2.54 in the Alzheimer’s Disease Assessment Scale–Cognitive Subscale 12 (ADAS-Cog-12), a standard cognitive measure commonly used in clinical trials for AD. The study was conducted in 34 hospitals in China and involved 818 participants.

Oligomannate was found to be safe and well tolerated. Adverse effects were comparable between the drug and the placebo. Although full data on the drug have not yet been published, the drug is expected to be available in China by the end of 2019. The company will have to submit additional research on the drug’s pharmacological mechanism, long-term safety and effectiveness. Early next year, the company plans to initiate a global Phase III study (GREEN MEMORY) in the US, Europe and Asia.