BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 27 December 2012 at 9:00 a.m
Biotie reports top-line data from clinical study with nepicastat (SYN117) in post-traumatic stress disorder
Biotie today reported top-line data from a Phase 2 study evaluating its dopamine beta hydroxylase inhibitor nepicastat (SYN117) in combat veterans suffering from post-traumatic stress disorder (PTSD). The study was funded by the U.S. Department of Defense and conducted as an Investigator-initiated study in the United States using clinical trial material supplied by Biotie.
Treatment with nepicastat was not effective in relieving PTSD-associated symptoms when compared to placebo. Nepicastat was generally well tolerated.
"We are disappointed with the results of this trial and will work with the study investigators to analyze and understand the data in more detail before deciding on next steps with nepicastat in PTSD", said Timo Veromaa, President and CEO of Biotie. "Independent of these results, we will continue to develop nepicastat in cocaine dependence in partnership with the U.S. National Institute of Drug Abuse (NIDA). We expect the first patients to be enrolled into a Phase 2 study in Q1 2013."
Turku, 27 December, 2012
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ABOUT THE STUDY (ClinicalTrials.gov identifier: NCT00659230)
The completed Phase 2 study was a randomized, placebo-controlled, double-blind study conducted in 100 combat veterans fulfilling diagnostic criteria for PTSD. It was conducted at 4 VA Medical Centers in the United States, with Dr. Lori Davis from Tuscaloosa VA Medical Center as the Principal Investigator.
The subjects were randomized in a 1:1 ratio to receive either 120 mg/day nepicastat or matching placebo for 6 weeks under double-blind conditions. Thereafter, subjects could continue on open-label study drug for an additional 8 weeks.
Efficacy was evaluated with the Clinician-Administered PTSD Scale (CAPS); the primary efficacy variable was the CAPS hyperarousal subscale (CAPS-D). Safety and tolerability were assessed with standard methods, including adverse event inquiries and laboratory analyses.
ABOUT NEPICASTAT (SYN117)
Nepicastat is an orally administered, potent and selective inhibitor of the enzyme dopamine beta hydroxylase (DBH), the enzyme responsible for the conversion of dopamine into norepinephrine. The compound has demonstrated potential as a treatment for cocaine dependence and PTSD.
Nepicastat was licensed from Roche in 2007.
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's most advanced product, Selincro(TM) (nalmefene), licensed to Lundbeck A/S, has on 14 December 2012 received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending marketing authorization of Selincro(TM) for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high level of alcohol consumption. In addition, Biotie has a strategic collaboration with UCB Pharma S.A. covering tozadenant which has successfully completed a Phase 2b study in 420 patients with advanced Parkinson's disease. Biotie shares are listed on NASDAQ OMX Helsinki Ltd.