Biotie reports top-line data from clinical study with nepicastat (SYN117) in post-traumatic stress disorder
ET | Source:Biotie Therapies
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
Turku, 27 December, 2012
Biotie Therapies Corp.
President and CEO
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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
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.
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