Avicena Announces Start of Enrollment in NIH Parkinson's Disease Trial

Avicena announced that its NIH collaborator and sponsor, the National Institute of Neurological Disorders and Stroke (NINDS), has initiated patient enrollment in a Phase III efficacy trial of PD-02, Avicena's lead Parkinson's disease drug candidate. PD-02 is an ultra-pure form of creatine made under strictly controlled drug manufacturing guidelines to not contain harmful neurotoxins that may be present in common types of creatine.

This will be one of the largest trials in the history of the NINDS, Avicena said. The NINDS has agreed to provide complete funding for the five-year trial to evaluate PD-02's potential to slow the progression of Parkinson's disease. Designed as a double-blind, placebo-controlled study, the trial is expected to enroll more than 1,720 Parkinson's patients at more than 50 trial sites across the U.S. and Canada.

As part of its ongoing collaboration with the NINDS, Avicena will supply the drug candidate, PD-02, and placebo for this trial. Under terms of the collaboration, Avicena will have rights to the study's findings for use in its new drug application submission to the FDA.

Recently, Avicena met a necessary precondition for beginning the NINDS-sponsored Phase III Parkinson's disease trial by completing the dose-escalation portion of a self-funded chronic toxicology study of PD-02. The journal Neurology has also published results from a Phase II study where PD-02 demonstrated a rate of disease progression that was lower than the threshold for futility.