Finnish biotechnology and pharmaceutics firm Biotie Therapies has completed patient enrolment in a Phase II trial investigating nepicastat for cocaine dependence.
A total of 179 patients have been enrolled in the 11-week trial, which is being carried out at ten 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.
According to the company, top-line results from the Phase II trial are expected to be announced by the end of this year.
Biotie CMO Stephen Bandak said: "The extraordinary commitment that both NIDA and the trial investigators have shown for this programme has helped the study exceed the already ambitious enrollment targets.
"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."
Nepicastat is an orally administered, potent and selective inhibitor of the enzyme dopamine beta-hydroxylase (DBH) that converts dopamine into norepinephrine.
Similar to many other addictions, cocaine dependence is driven by dysregulation in the dopamine-reward system.
The company said that inhibition of DBH by nepicastat increases levels of dopamine, which may reduce craving for cocaine, and reduces the levels of norepinephrine, which might decrease pleasurable responses the drug and potential for stress-induced relapse following withdrawal.
Nepicastat is currently in Phase II development for cocaine dependence and a previously completed placebo-controlled Phase IIa trial in non-treatment seeking cocaine addicts showed that nepicastat had a favourable safety profile and was well-tolerated when administered with cocaine.
The company retains full rights to nepicastat and will be able to use data from trials conducted with NIDA to support future potential regulatory submissions.