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    Home > Active Ingredient News > Study of Nervous System > FDA Approves Mannat Sodium Capsules (Nine Phase One®) for International Phase II Clinical Trial of Parkinson's Disease

    FDA Approves Mannat Sodium Capsules (Nine Phase One®) for International Phase II Clinical Trial of Parkinson's Disease

    • Last Update: 2022-01-24
    • Source: Internet
    • Author: User
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    On January 13, the U.
    S.
    Food and Drug Administration (FDA) notified in writing that the original new drug for Alzheimer's disease, Mannat Sodium Capsules (code: GV-971, trade name: Nine Phase One®), was approved for the treatment of Parkinson's disease.
    The international multi-center phase II clinical trial (IND 159315), the approval will be officially effective from 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 that it is related to α-synuclein aggregation, neuroinflammation and oxidative stress, mitochondrial dysfunction
    .

    In recent years, more and more studies have shown that the intestinal flora is highly correlated with the occurrence and development of Parkinson's disease
    .

    Nine Phase One® is the world's first drug targeting the brain-gut axis for the treatment of Alzheimer's disease.
    It can reduce neuroinflammation in the brain by regulating the intestinal flora and reducing abnormal metabolites of the flora

    .

    On this basis, the research team carried out a preclinical study on the treatment of Parkinson's disease based on the common pathological mechanism of neurodegenerative diseases, and found that the nine-phase one® can regulate the imbalance of intestinal flora and inhibit the α-synapse Aggregation of nucleoproteins, reducing α-synuclein deposition in the gut and brain, reducing neuroinflammation and protecting dopaminergic neurons, improving motor and non-motor symptoms
    .

    The international multi-center phase II clinical trial will be a 36-week multi-center randomized, double-blind, placebo-controlled parallel-controlled trial and a 36-week open-label extended treatment period.
    It plans to include 300 patients with early Parkinson's disease for clinical trials.
    Subjects, conducted at 30 clinical centers in North America and Asia Pacific, to evaluate the efficacy and safety of Phase I® in the treatment of early-stage Parkinson's disease

    .

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