An Innovative Anti-Alzheimer's Disease Drug from China Meets the Primary Endpoint of a Phase Ⅲ Clinical Trial

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Date：2018-07-17

Tuesday, July 17, 2018

SHANGHAI, CHINA -- Shanghai Green Valley Pharmaceutical Co., Ltd. (Green Valley) today announced that its Phase 3 Study of Sodium Oligomannurarate (GV-971) Capsule on mild-to-moderate Alzheimer's disease (AD) met its primary endpoint. GV-971 was co-discovered and co-developed by Ocean University of China (OUC), Shanghai Institute of Materia Medica (SIMM) of Chinese Academy of Sciences and Green Valley. After over 21 year comprehensive investigation, GV-971 is the first multi-targeting and carbohydrate-based drug for the treatment of AD in the world.

This randomized, double-blinded and placebo-controlled clinical trial in China aimed to evaluate safety and efficacy of GV-971 on study participants with mild-to-moderate AD (MMSE score ranged from11 to 26). On the treatment arm, subjects took 450mg GV-971 orally twice each day for 36 weeks. The primary endpoint was the improved change of the Alzheimer's Disease Assessment Scale-cognitive (ADAS-cog) score after 36-week treatment in the GV-971 arm compared to that in the placebo control. Data showed that GV-971 was effective in improving cognition. In the perspective of adverse events, GV-971 showed a similar profile to that of placebo control. Notably, no amyloid-related imaging abnormality (ARIA) was observed.

GV-971 is an oligosaccharide extracted from brown algae. Independent animal investigations also showed that GV-971 could remodel immune homeostasis, reduce neuro-inflammation, and improve cognition impairment by reconditioning the dysbiosis of gut microbiota.

Alzheimer's disease is a chronic neurodegenerative disorder characterized by a progressive loss of cognitive function. According to Alzheimer's Disease International, world-wide there are approximately 48 million patients with Alzheimer's disease, and this number is expected to reach 130 million by 2050 due to a rapid growth of the aging population.

The success of GV-971 is made possible by the determination and hard-working of GV-971 team members, which was originally discovered by Ocean University of China and was further co-developed by SIMM and Green Valley. GV-971 offers an innovative and multi-targeting mechanism of action. It opens a new avenue for the treatment of AD, and provides patients with a novel solution and new hope. GV-971 is expected to lead the new wave of carbohydrate-based drug development, and shows that innovative medicines in China can have profound influence world-wide.

Green Valley plans to submit the marketing authorization application of GV-971 for treatment of mild-to-moderate AD to the China National Drug Administration later this year.

Media Clippings:

xinhuanet.com: http://www.xinhuanet.com/2018-07/17/c_1123139354.htm

CCTV.com:xinhuanet.com: http://www.xinhuanet.com/2018-07/17/c_1123139354.htm

China Daily:http://cn.chinadaily.com.cn/2018-07/17/content_36594268.htm

cankaoxiaoxi.com: http://www.cankaoxiaoxi.com/science/20180717/2294302.shtml

WHB.cn: http://culture.whb.cn/zhuzhan/yiliao/20180717/204342.html

jfdaily-Shobserver: https://web.shobserver.com/wx/detail.do?id=96752&time=1531818431122&from=singlemessage&isappinstalled=0

DRAGON TV：http://www.kankanews.com/a/2018-07-17/0018517542.shtml

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