Innovative Alzheimer's Treatment from China Concludes Phase 3 Clinical Trials Green Valley plans to submit the application for treatment to the China National Drug Administration this Year
SHANGHAI, July 19, 2018 /PRNewswire/ -- Shanghai Green Valley Pharmaceutical Co., Ltd. (Green Valley) today announced that its Phase 3 Study of Sodium Oligomannurarate (GV-971) Capsules on mild-to-moderate Alzheimer's disease met its primary endpoint.
This randomized, double-blinded and placebo-controlled clinical trial in China aimed to evaluate safety and efficacy of GV-971, a multi-targeting oligosaccharide drug, on study participants with mild-to-moderate Alzheimer's disease (MMSE score ranged from 11 to 26). On the treatment arm, subjects took 450mg GV-971 orally twice each day for 36 weeks. The primary endpoint showed the improved change of the Alzheimer's Disease Assessment Scale-cognitive (ADAS-cog) score after the 36 week GV-971 treatment compared to the placebo control. Data showed that GV-971 significantly improved the cognition impairment. Regarding the rate of adverse events, GV-971 showed a similar profile to that of the placebo control, no amyloid-related imaging abnormalities (ARIA) were observed.
Alzheimer's disease is a chronic neurodegenerative disorder characterized by a progressive loss of cognitive function. According to Alzheimer's Disease International, there are approximately 48 million patients world-wide with Alzheimer's disease, and this number is expected to reach 130 million by 2050 due to a rapid growth of the aging population.
Green Valley plans to submit the marketing authorization application of GV-971 for treatment of mild-to-moderate Alzheimer's disease to the China National Drug Administration later this year.
