Biotie announces start of tozadenant Phase3 Study in Parkinson's disease
Biotie announces the start of the Phase 3 clinical study of tozadenant, an investigational adenosine A2a receptor antagonist, in patients with Parkinson's disease (PD) experiencing levodopa related end-of-dose "wearing-off".
The Phase 3 study (TOZ-PD) is a randomized, double-blind, placebo controlled trial that will evaluate efficacy and safety of tozadenant compared to placebo in 450 PD patients experiencing end-of-dose wearing off episodes. Participants will be randomized to receive twice daily doses of 60 mg or 120 mg of tozadenant or placebo, in addition to their standard anti-PD medications, for 24 weeks. The primary endpoint will be reduction in time spent in the "off" state in patients taking tozadenant as compared to placebo between baseline and week 24. The placebo-controlled period will be followed by a 52 week open label treatment period to collect additional safety data. As previously announced, Biotie Therapies reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) of this study.
A successful outcome to the study will confirm the safety and efficacy observed in the previously completed Phase 2b study of tozadenant in this indication and provide a second pivotal study to support submission of an New Drug Application (NDA) for the use of tozadenant as adjunctive treatment to levodopa in patients experiencing end-of-dose wearing off.
Based on current estimates, top-line data from the double-blind portion of the study is expected to be available by the end of 2017.