Biotie Announces Start of Clinical Study With Nepicastat (SYN117) in Cocaine
TURKU, FINLAND -- (Marketwired) -- 05/10/13 -- BIOTIE THERAPIES
CORP. STOCK EXCHANGE RELEASE 10 May 2013 at 9.00 a.m.
Biotie announces start of clinical study with nepicastat (SYN117) in
Biotie Therapies today announced the start of a Phase 2 clinical
study evaluating nepicastat (SYN117) in cocaine dependence. The
National Institute on Drug Abuse (NIDA) at the US National Institutes
of Health is funding the conduct of the study under a Collaborative
Research and Development Agreement (CRADA) signed in December 2011.
The study is a randomized, double-blind placebo-controlled 11-week
trial and is expected to enroll about 180 treatment-seeking
cocaine-dependent subjects. The study will be conducted at
approximately 12 US clinics specializing in the treatment of drug
The trial is expected to take approximately two years to complete.
Turku, 10 May 2013
Biotie Therapies Corp.
President and CEO
NASDAQ OMX Helsinki Ltd
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.
Nepicastat has also been evaluated as a potential treatment for
post-traumatic stress disorder (PTSD). In December 2012, Biotie
announced top-line data from an investigator-initiated Phase 2 study
in PTSD. In this study, nepicastat was generally well tolerated but
was not effective in relieving PTSD-associated symptoms when compared
to placebo. Biotie is evaluating data from this study in further
detail and will then decide on next steps with nepicastat in PTSD
Biotie holds full rights to nepicastat and will be able to use data
from studies conducted with NIDA to support future potential
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 (nalmefene), licensed to H.
Lundbeck A/S, has on 28 February 2013 received European marketing
authorization 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 is transitioning into Phase
3 development for Parkinson's disease. Biotie shares are listed on
NASDAQ OMX Helsinki Ltd.
For further information, please contact:
Dr. Stephen Bandak
Chief Medical Officer
tel. +1 650 296 0946 (Pacific Time zone)
Investor Relations Manager
tel. +358 2 274 8900
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