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.
