TURKU, FINLAND--(Marketwire - July 05, 2012) - Biotie today announced that enrollment is complete in its Phase 2b trial evaluating the safety and efficacy of tozadenant in Parkinson's disease ("PD"). Biotie now expects the top-line data from this study to be available at around the end of 2012, previous guidance was H1 2013.
The 12 week, double-blind, placebo-controlled, dose-finding study, being conducted in the US, Canada, Chile, Argentina, Ukraine and Romania, enrolled 420 PD patients experiencing levodopa related end of dose wearing off. In these patients, treatment with levodopa is insufficient to control PD symptoms until their next dose, resulting in an 'off' period when symptoms reappear. The primary goal of the Phase 2b study is to determine the efficacy of tozadenant in reducing the mean number of hours per day spent in the 'off' state. The trial will also assess the safety of tozadenant and its impact on various measures of motor symptom severity, dyskinesia and non-motor symptoms.
"Thanks to the dedication of our investigators and staff, recruitment in this large study has been completed earlier than anticipated." said Timo Veromaa, President and CEO of Biotie. "We look forward to finalizing the study and evaluating the potential of tozadenant as a treatment for Parkinson's disease."
Biotie has granted UCB Pharma S.A. a license for exclusive, worldwide rights to tozadenant. Pending evaluation of the results of the ongoing study UCB Pharma will be responsible for conducting the Phase 3 program and commercializing tozadenant.
In Turku, 5 July 2012
Biotie Therapies Corp.
President and CEO
NASDAQ OMX Helsinki Ltd
About tozadenant (SYN115)
Tozadenant is an oral, potent and selective adenosine A2a receptor antagonist, which enters the brain and modulates regions associated with motor and non-motor function. Biotie obtained development and commercialization rights to tozadenant from Roche in 2007 for selected diseases of the central nervous system.
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 the development of drugs for neurodegenerative and psychiatric disorders (e.g. Parkinson's disease, Alzheimer's disease and other cognitive disorders, alcohol and drug dependence (addiction) and post traumatic stress disorder), and inflammatory and fibrotic liver disease.The company has a strong and balanced development portfolio with several innovative small molecule and biological drug candidates at different stages of clinical development. Biotie's products address diseases with high unmet medical need and significant market potential.
Biotie has a strategic collaboration with UCB Pharma S.A. covering tozadenant for Parkinson's disease. The Marketing Authorization Application for Biotie's most advanced product, SelincroTM (nalmefene) for alcohol dependence was filed in the EU by our partner H. Lundbeck A/S and was accepted for review by the European Medicines Agency in December 2011. Biotie shares are listed on NASDAQ OMX Helsinki Ltd.