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FDA to rule on testing of Lyme disease drug

Article

The Food and Drug Administration is expected to soon decide whether VGV-L, a drug candidate from Viral Genetics targeting chronic Lyme disease, can move to human trials.

Washington - The Food and Drug Administration is expected to soon decide whether VGV-L, a drug candidate from Viral Genetics targeting chronic Lyme disease, can move to human trials.

PRWeb reports that company researchers, working in conjunction with various institutions, submitted a pre-IND (Investigational New Drug) briefing to the FDA, an early step toward eventual clinical testing of the drug.

The pre-IND submission comes after more than two years of testing. A protocol for a human clinical trial was submitted this month to the FDA along with test results.

Existing research has established a link between certain immune characteristics and resistance or susceptibility to developing chronic inflammation as a consequence of infection. The Viral Genetics research team proposes restoring a healthy immune response by replacing or removing the self-peptides with a targeted peptide.

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