Green Valley Pharmaceutical Co., Ltd. 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).

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.

GV-971 showed a similar profile to that of the placebo, no amyloid-related imaging abnormalities (ARIA) were observed.

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.