Green Valley (Shanghai) Pharmaceuticals Co., Ltd. received the letter from the US Food and Drug Administration (FDA) on the Investigational New Drug (IND) application for the global multi-center phase-II clinical trial of Oligomannate (marketed as “GV-971”), the company’s innovative drug for treating Alzheimer’s disease (AD). The letter indicated the “Study May Proceed” with the proposed clinical investigation in the treatment of patients with early-stage Parkinson’s disease (PD). The IND effective date is December 16, 2021.
As the second most common neurodegenerative disease after AD, although the pathogenesis of PD is not exactly known, it is generally believed that the disease is associated with α-synuclein aggregation, neuroinflammation, oxidative stress, and mitochondrial dysfunction. In recent years, increasing body of evidence has demonstrated that the gut microbiota is highly correlated with PD’s occurrence and development.
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Being the world’s first AD drug that targets the gut-brain axis, GV-971 reduces peripheral and central inflammation1 by reconditioning the gut microbiota and inhibiting the abnormal balance of gut microbiota-derived metabolites. Based on such findings, the research team at Green Valley Research Institute carried out preclinical research on GV-971’s effect on PD based on the common pathological mechanism of neurodegenerative diseases, and found that the drug is able to regulate gut microbiota dysbiosis, suppress α-synuclein aggregation in both the gut and the brain, reduce neuroinflammation, protect dopaminergic neurons, and improve motor and non-motor symptoms.
The global multi-center phase-II clinical trial will be a 36-week, multi-center, randomized, double-blind, placebo-controlled trial, followed by a 36-week open-label extension period. The trial plans to enroll 300 patients with early-stage PD, and will be conducted at 30 clinical centers in North America and Asia Pacific region to evaluate the efficacy and safety of GV-971 in the treatment of early-stage PD.
On November 2, 2019, China’s National Medical Products Administration approved GV-971 for the “treatment of mild-to-moderate AD and improving cognitive function”, after fast-track review for the drug. The phase-III trial of GV-971 in China was conducted in 34 Tier-1 hospitals across the country in 818 patients with mild-to-moderate AD. Results of the 36-week trial demonstrated that GV-971 had significantly improved cognitive function in mild-to-moderate AD patients, and was safe and well tolerated with side effects comparable to the placebo1.
In April 2020, the application for the global multi-center phase-III clinical trial of GV-971 was approved by the U.S. FDA. The global trial has been subsequently approved by regulatory agencies in 10 countries and regions, including , Canada, China, Australia, France, Czech and others. Currently, 154 clinical centers in these countries have been activated, with 949 patients screened and 292 patients randomized. The trial is scheduled for completion by 2025, followed by global submission of new drug application.
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