Pharmaceuticals company Shanghai Green Valley Pharmaceuticals, China said on Monday that it has received approval from the US Food and Drug Administration (FDA) for the Investigational New Drug (IND) application for the GV-971 international multi-center Phase III clinical study in Alzheimer's.

The company added that GV-971 is an orally administered mixture of acidic linear oligosaccharides derived from marine brown algae.

Based on the preclinical studies on its mechanism of action, GV-971 can improve cognitive function by reshaping the balance of gastrointestinal microbiota, inhibiting the abnormal increase of specific metabolites of this gut microbiota, reducing peripheral and central inflammation, β-amyloid deposition and hyperphosphorylation of Tau protein. The gut microbiota is highly correlated with the incidence of Parkinson's disease, depression, autism and other central nervous system diseases, stated the company.

Under the 12-month double-blind treatment period and six month open-label Phase III clinical trial of GV-971, the company plans to enroll 2000 patients with mild to moderate Alzheimer 's disease at 200 sites in North America, Europe and Asia-Pacific regions including China. The trial is planned to be completed in 2024 and the new drug registration application (NDA) submission is expected by 2025.