Oligomannate (compound code GV-971), a drug developed in China to improve cognitive function for those with mild to moderate Alzheimer’s disease, was formally approved on April 8 by the US Food and Drug Administration (FDA) for international multi-center Phase III clinical study in the U.S..

A formal decision letter from the US Food and Drug Administration on the Investigational New Drug (IND) application for GV-971 indicated the “Study May Proceed” with the proposed clinical investigation in the treatment of patients with Alzheimer’s disease. The IND effective date is April 3, 2020.

Geng Meiyu, key inventor of the drug GV-971, also a researcher of Shanghai Institute of Materia Medica under Chinese Academy of Sciences, shows the sample model of the new drug in Shanghai. [IMAGE: BLOOMBERG]

GV-971 was developed jointly by Ocean University of China, the Shanghai Institute of Materia Medica (SIMM) of the Chinese Academy of Sciences and Green Valley, in a 22-year study.

The leading inventor of this new medicine is Professor Geng Meiyu from SIMM.

The drug GV-971 is an orally administered mixture of acidic linear oligosaccharides derived from a 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 and inhibiting abnormal increase of specific metabolites of gut microbiota, thus 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.

Oligomannate obtained conditional approval from the China NMPA for improving the cognitive function of patients living with mild to moderate Alzheimer's disease on November 2, 2019, and was launched in China on December 29, 2019.

The international Phase III clinical trial of GV-971 plans to enroll more than 2,000 patients with mild to moderate Alzheimer’s disease, and consists of a 12-month double-blind treatment period and a six-month open-label period. The trial study will be conducted at 200 sites in North America, Europe and the Asia-Pacific regions including China, and is planned to be completed in 2024. New drug application (NDA) submission is expected by 2025.

Source: Chinese Academy of Sciences