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an innovative anti-alzheimer's disease drug from china meets the primary endpoint of a phase ⅲ clinical trial

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.

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