Avicena will supply the National Institute of Neurological Disorders and Stroke (NINDS) with PD-02, the company's lead Parkinson's disease (PD) drug candidate, for a Phase III trial being planned by the Institute. The trial is designed to evaluate PD-02's potential to slow the progression of Parkinson's disease.
PD-02 has demonstrated the potential to improve neurological function in patients with ALS, Huntington's disease, and Parkinson's disease. The company reports that in preclinical studies, PD-02 showed significant neuroprotective properties, including protection of the dopaminergic cells which are affected in Parkinson's disease.
As part of its ongoing collaboration with NINDS, Avicena will provide PD- 02 and placebo for the trial and fund a related chronic toxicology study. In turn, Avicena has the right to utilize the study's findings for an NDA submission to the FDA.