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news.In a phase II futility study, Avicena Group's proprietary drug candidate PD-02 and the antibiotic minocycline have both produced encouraging results in the treatment of Parkinson's disease.
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Data demonstrated that neither PD-02 nor minocycline was found to be futile as compared to predetermined thresholds, suggesting both agents may be worthy of further consideration as potential therapeutics for the condition.
Thes randomized, phase II, multi-center, double-blind trial enrolled 200 early, untreated Parkinson’s disease patients into three different treatment arms – PD-02 10g per day; minocycline 200mg per day; or placebo.
After 12 months of daily treatment, investigators found that the rate of disease progression for both PD-02 and minocycline was lower than the threshold for futility, as measured by the unified Parkinson’s disease rating scale (UPDRS).
Additionally, PD-02 was found to be safe and generally well-tolerated by the subjects during this study.
“While these findings were encouraging for both PD-02 and minocycline, we want to emphasize that further research would be needed to determine if either agent can slow the progression of Parkinson’s disease,” said Dr Karl Kieburtz, director of the Clinical Trials Coordination Center at the University of Rochester, New York.
Results from this study, which was sponsored by the US National Institute of Neurological Disorders and Stroke, were published in the journal Neurology.