Promising Phase 3 Results For Green Valley’s Alzheimer’s Drug

The marine-derived compound GV-971 was found to be safe and effective for treating mild-to-moderate Alzheimer’s disease.

AsianScientist (Dec. 5, 2018) – Shanghai’s Green Valley Pharmaceutical Co., Ltd. has announced promising findings from a Phase 3 clinical trial of GV-971, a multi-targeting carbohydrate-based drug for the treatment of mild-to-moderate Alzheimer’s disease.

Some 50 million people worldwide suffer from Alzheimer’s disease, displaying symptoms such as cognitive impairment that worsen over time. As aging populations increase, the World Health Organization estimates that the number of individuals affected by Alzheimer’s disease is expected to triple by 2050. However, there are limited effective treatments for the debilitating condition.

Led by Dr. Xiao Shifu from Shanghai Jiao Tong University, Dr. Zhang Zhenxin from Peking Union Medical College Hospital and Professor Geng Meiyu of the Shanghai Institute of Materia Medica, researchers conducted a double-blind, placebo-controlled, multi-center Phase 3 trial of the drug GV-971.

“GV-971 is a novel, marine-derived oligosaccharide, which has multi-targeting mechanisms, including inhibition of amyloid-β fibril formation and neuroinflammation,” said Geng.

Involving 818 patients across 34 sites in China, the trial participants were 50-85 years old and had been diagnosed with mild-to-moderate Alzheimer’s disease based on cognitive tests and MRI scans. They were randomized to receive either 450 milligrams of GV-971 twice per day by oral administration, or placebo, for a treatment period of 36 weeks.

GV-971 resulted in statistically significant improvement in patients, based on their Alzheimer’s Disease Assessment Scale-Cognitive 12 scores. A statistically significant difference between GV-971 and placebo was observed as early as week four of treatment and was sustained at each follow-up assessment visit.

The twice per day oral drug treatment was found to be safe and well tolerated. The researchers also noted that there were no statistically significant group differences in participants who experienced severe adverse effects from GV-971 consumption.


Source: Chinese Academy of Sciences; Photo: Shutterstock.
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