On January 13, the U.S. Food and Drug Administration (FDA) notified in writing that it had approved the launch of an international multicenter Phase II Clinical Trial (IND 159315) of the original drug for the treatment of Alzheimer's disease, N.R. Mannitsone Capsules (codename GV-971, trade name: Phase IX I), effective December 16, 2021.
As the second most common neurodegenerative disease after Alzheimer's disease, the pathogenesis of Parkinson's disease is still inconclusive, but it is generally believed to be related to α-synuclein aggregation, neuroinflammation, oxidative stress, and mitochondrial dysfunction. In recent years, more and more studies have shown that the intestinal flora is highly associated with the occurrence and development of Parkinson's disease.
Phase IX One is the world's first Alzheimer's disease treatment drug that targets the cerebral intestinal axis, which reduces the abnormal metabolites of the intestinal flora by regulating the intestinal flora and reducing abnormal metabolites in the brain.
On this basis, the research team carried out a preclinical study of the treatment of Parkinson's disease in stage IX based on the common pathological mechanism of neurodegenerative diseases, from which it was found that stage 9 can regulate intestinal flora imbalance, inhibit the aggregation of α-synuclein, reduce the deposition of α-synuclein in the intestine and brain, reduce neuroinflammation and protect dopaminergic neurons, and improve motor and non-motor symptoms.
The international multicenter Phase II clinical trial will be a 36-week multicenter randomized, double-blind, placebo parallel controlled trial with a 36-week open-endurance phase of treatment, with 300 patients with early-stage Parkinson's disease as clinical trial participants, to be conducted in 30 clinical centers in North America and Asia Pacific to evaluate the efficacy and safety of Phase IX-1 treatment of early-stage Parkinson's disease.