Biotie provides portfolio update on tozadenant
Posted: 20 February 2015 |
Biotie has announced further detail on its clinical development plan for tozadenant, an adenosine A2a antagonist in development for Parkinson’s disease (PD)…
Biotie has announced further detail on its clinical development plan for tozadenant, an adenosine A2a antagonist in development for Parkinson’s disease (PD).
Biotie plans to conduct one Phase 3 study in 882 PD patients experiencing levodopa related end-of-dose ‘wearing-off’ (motor fluctuations) in which participants will be randomized in a double-blind manner to receive twice daily doses of 60mg or 120mg of tozadenant or placebo in addition to their standard anti-PD medications, for 24 weeks.
The primary endpoint will be time spent in the “off” state in patients taking tozadenant as compared to placebo between baseline and week 24. Secondary endpoints will include “on” time without troublesome dyskinesia, the Unified Parkinson’s Disease Rating Scale, Clinical Global Impression of Change and Patient Global Impression of Change. The placebo-controlled period will be followed by a 52 week open label treatment period to collect additional clinical safety data. The planned Phase 3 study is expected to start recruiting patients in the United States, Canada and selected European countries in the middle of 2015. Based on current estimates, top-line data is expected to be available by the end of 2018.
Biotie has previously reported positive data from a 420-patient Phase 2b study evaluating tozadenant in PD patients experiencing levodopa related end-of-dose ‘wearing-off’. Full data from this trial was published in Lancet Neurology in 20141. The trial met its primary endpoint of a highly significant decrease in “off” time vs. placebo, as well as demonstrating efficacy across multiple secondary endpoints. The Phase 3 protocol will largely replicate that of the Phase 2b study. Biotie expects that the published Phase 2b study will be considered the first of two pivotal studies required for registration for tozadenant in PD patients with end-of-dose ‘wearing-off’.
Biotie is considering financing options which may involve a capital raise to fully fund the tozadenant Phase 3 program to approval.
