On April 8, 2020, Shanghai Green Valley Pharmaceuticals, China received the formal decision letter from the US Food and Drug Administration (FDA) on the Investigational New Drug (IND) application for the GV-971 international multi-center Phase III clinical study. The letter indicated the “Study May Proceed” with the proposed clinical investigation in the treatment of patients with Alzheimer’s disease, and the IND effective date is April 3, 2020.
GV-971 is an orally administered mixture of acidic linear oligosaccharides derived from marine brown algae. Preclinical studies on its mechanism of action shows that 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. A growing body of evidence reveals that gut microbiota is highly correlated with the incidence of Parkinson's disease, depression, autism and other central nervous system diseases. GV-971 obtained conditional approval from China NMPA for improving the cognitive function of patients living with mild to moderate Alzheimer's disease on November 2, 2019, and launched in China on December 29, 2019.
Based on the full data package of GV-971 nonclinical, clinical, chemistry, manufacturing and control (CMC), and the China Phase III clinical efficacy and safety outcomes used for the NDA approval by the China NMPA, Green Valley submitted the IND application to the FDA directly for an international multi-center Phase III clinical trial and obtained approval, which will shorten the overall process to bring the new hope to patients suffering from Alzheimer's disease worldwide.
Green Valley will continue to work with IQVIA (formerly known as Quntile), the world’s largest contract research organization (CRO) for clinical trial operation, to manage the Phase III clinical trial of GV-971. The study, which plans to enroll more than 2000 patients with mild to moderate Alzheimer ’s disease, and comprises of a 12-month double-blind treatment period and a 6-month open-label period, will be conducted at 200 sites in North America, Europe, and Asia-Pacific regions including China. Jeffrey Cummings, the winner of the Bengt Winblad Lifetime Achievement Award (2018) from National Alzheimer's Association of America and Professor of Neurotherapeutics and Drug Development in the Neurological Institute, Cleveland Clinic, has been leading the clinical trial design and will serve as the Chairman of Scientific Innovation Committee (SIC) for Green Valley. Leading principal investigators (PI) include Martin Farlow, Roy Jones, Bruno Vellas and other world-renowned experts. The leading PIs in China are Professor Jia Jianping of Xuanwu Hospital of Capital Medical University and Professor Xiao Shifu of Shanghai Mental Health Center.
The phase III clinical trial is planned to be completed in 2024, and the new drug registration application (NDA) submission is expected by 2025.