Biotie: nepicastat study in cocaine dependence completes enrollment ahead of schedule - top-line data expected around end 2014
ET | Source:Biotie Therapies
BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 27 May 2014 at 9.00
Biotie: nepicastat study in cocaine dependence completes enrollment ahead of
schedule - top-line data expected around end 2014
Biotie Therapies today announced that patient enrollment into the Phase 2 study
investigating nepicastat for cocaine dependence has been completed ahead of
schedule. The 11-week, 179-patient study is being conducted at 10 US clinics
under a Collaborative Research and Development Agreement (CRADA) with the
National Institute on Drug Abuse (NIDA) at the US National Institutes of Health.
Top-line results from the study are expected around the end of 2014.
"The extraordinary commitment that both NIDA and the trial investigators have
shown for this program has helped the study exceed the already ambitious
enrollment targets", commented Dr. Stephen Bandak, CMO of Biotie. "We look
forward to completion of the clinical treatment phase and await the top-line
results, scheduled to be available around year end, with great interest."
Turku, 27 May 2014
Biotie Therapies Corp.
President and CEO
For further information, please contact:
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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.
Nepicastat is currently in Phase 2 development for cocaine dependence. A
previously completed placebo-controlled Phase 2a study in non-treatment seeking
cocaine addicts showed that nepicastat had a favourable safety profile and was
well tolerated when administered with cocaine. An 11-week Phase 2 safety and
efficacy trial in 179 treatment seeking cocaine addicted patients, funded by the
U.S. National Institute on Drug Abuse under a Collaborative Research and
Development Agreement, has completed patient enrollment, and top-line results
are expected around the end of 2014.
Biotie retains full rights to nepicastat and will be able to use data from
studies conducted with NIDA to support future potential regulatory submissions.
Biotie is a specialized drug development company focused on products for
neurodegenerative and psychiatric disorders. For the past years, Biotie has
successfully operated a strategy built around search, profile and partner. This
has delivered Selincro (nalmefene) for alcohol dependence, which received
European marketing authorization in February 2013 and is currently being rolled
out across Europe by partner H. Lundbeck A/S, and tozadenant, a novel A2a
antagonist which is transitioning into Phase 3 development for Parkinson's
disease and for which Biotie holds exclusive, global rights. Biotie is actively
developing its pipeline assets, including SYN120, a unique potent 5-HT6/5-HT2a
dual antagonist for which Biotie expects to conduct a Phase 2 study in
Alzheimer's disease; nepicastat, a selective inhibitor of dopamine beta
hydroxylase which is currently in a Phase 2 study, fully funded by NIDA, for
treatment seeking cocaine addicts; and BTT-1023, a monoclonal antibody targeting
Vascular Adhesion Protein 1 for which Biotie intends to conduct a Phase 2 study
in primary sclerosing cholangitis, a rare fibrotic disease of the liver.
Biotie's shares are listed on NASDAQ OMX Helsinki.
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