In the news release, Innovative Alzheimer's Treatment from China Concludes Phase 3 Clinical Trials, issued 19-Jul-2018 by Shanghai Green Valley Pharmaceutical Co., Ltd over PR Newswire, we are advised by the company that the second sentence should start with "On the treatment arm," and the final two sentences in the second paragraph should read "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." rather than "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. GV-971 showed a similar profile to that of the placebo, no amyloid-related imaging abnormalities (ARIA) were observed." as originally issued inadvertently. The complete, corrected release follows:
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.
