An Innovative Anti-Alzheimer’s Disease Drug from China Meets the Primary Endpoint of A Phase 3 Clinical Trial NDA Submission Anticipated Within this Year

Date:2018-07-17 Admin:green valley

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. Unlike monoclonal antibodies typically targeting limited sites of the Aβ species, GV971 can bind to multiple Aβ regions and in its different states and thus inhibits Aβ aggregation and destabilizes aggregated fibrils into monomeric nontoxic forms. 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.

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