Biotie Therapies Corp. (“Biotie”) announces top-line results from a Phase 2 clinical study with nepicastat (SYN117) in cocaine-dependent patients. When compared to placebo, nepicastat did not meet the primary efficacy endpoint of an increased proportion of subjects remaining abstinent from cocaine during the last two weeks of the treatment period. Nepicastat was generally well tolerated in the study. A comprehensive analysis of safety and efficacy data is ongoing.
“We are grateful to the study investigators and participating subjects for all their effort in completing the study, and to the National Institute on Drug Abuse (NIDA), whose funding and technical expertise provided us the opportunity to evaluate nepicastat in this difficult-to-treat disorder”, said Timo Veromaa, President and CEO of Biotie. “As a company, our immediate focus remains on commencing the tozadenant Phase 3 program in Parkinson’s disease in H1 2015, in line with our original schedule.”
The study enrolled 179 treatment-seeking cocaine-dependent subjects in a randomized, double-blind placebo-controlled trial, in which the duration of drug treatment was 11 weeks. The study was conducted at 10 US clinics specializing in the treatment of drug dependence and was funded by the National Institute on Drug Abuse (NIDA) at the US National Institutes of Health under a Collaborative Research and Development Agreement (CRADA).
Turku, 30 January 2015
Biotie Therapies Corp.
Timo Veromaa
President and CEO
Further information:
For further information, please contact:
Dr. Stephen Bandak, Chief Medical Officer
tel. +1 650 296 0946 (Pacific Time zone), email: stephen.bandak@biotie.com
Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8900, e-mail: virve.nurmi@biotie.com
Distribution:
NASDAQ OMX Helsinki Ltd
Main media
www.biotie.com
About nepicastat (SYN117)
Nepicastat is an orally administered, potent and selective inhibitor of the enzyme dopamine beta hydroxylase (DBH) which converts dopamine into norepinephrine. Like many other addictions, cocaine dependence is driven by dysregulation in the dopamine-reward system. Inhibition of DBH by nepicastat increases levels of dopamine, which may reduce craving for cocaine, and reduces the levels of norepinephrine, which may decrease the pleasurable responses to cocaine and the potential for stress-induced relapse following withdrawal. Biotie has previously conducted a placebo-controlled Phase 2a study in non-treatment seeking cocaine addicts. The study showed that nepicastat had a favourable safety profile and was well tolerated when administered with cocaine.
About Biotie
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.
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