TURKU, Finland, Feb. 20, 2015 (GLOBE NEWSWIRE) -- Biotie announces 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.
Turku, 20 February 2015
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About tozadenant (SYN115)
Tozadenant is an oral, potent and selective adenosine A2a receptor antagonist being developed for the treatment of Parkinson's disease. Tozadenant has displayed clinically relevant and statistically highly significant effects in Parkinson's disease, across multiple pre-specified evaluation metrics, in a 420 patient Phase 2b study completed in December 2012, and it is currently transitioning into Phase 3 development.
About Parkinson's disease
Parkinson's disease is the second most common neurodegenerative disorder, after Alzheimer's disease. It affects about one percent of people ages 65-69, rising to up to three percent of people who are 80 years and older. The symptoms of Parkinson's disease result from decreased dopamine production in regions of the brain controlling movement.
Biotie is a specialized drug development company focused on products for neurodegenerative and psychiatric disorders. Biotie's development has delivered Selincro (nalmefene) for alcohol dependence, which received European marketing authorization in 2013 and is currently being rolled out across Europe by partner Lundbeck. The current development products include tozadenant for Parkinson's disease, which is transitioning into Phase 3 development, and three additional compounds which are in Phase 2 development for cognitive disorders including Parkinson's disease dementia, cocaine dependence, and primary sclerosing cholangitis (PSC), a rare fibrotic disease of the liver.
1 Hauser RA, Olanow CW, Kieburtz KD, et al. Tozadenant (SYN115) in patients with Parkinson's disease who have motor fluctuations on levodopa: a phase 2b, double-blind, randomised trial. Lancet Neurol. 2014 Aug;13(8):767-76. doi: 10.1016/S1474-4422(14)70148-6. Epub 2014 Jul 6.
Source: Biotie Therapies Oyj