SYN117 (nepicastat) for the treatment of cocaine dependency and post traumatic stress disorder (PTSD)

SYN117 (nepicastat) is an orally administered, potent and selective inhibitor of the enzyme dopamine β-hydroxylase (DBH) which has potential application in the treatment of cocaine dependency and post traumatic stress disorder (PTSD). 

SYN117 for cocaine dependency

Cocaine dependency represents a major unmet medical need which has a large economic and social burden to society and for which there are currently no approved therapies. Like many other addictions, cocaine dependency is driven by a dysregulation in the dopamine reward system. Mechanistically, inhibition of DBH by SYN117 increases levels of dopamine (which reduces the craving for cocaine) and reduces the levels of norepinephrine (which decreases the pleasurable responses to cocaine and the potential for stress induced relapse following withdrawal).

Biotie has conducted a placebo controlled Phase 2a study in non-treatment seeking cocaine addicts. This study showed that SYN117 was safe and well tolerated when administered with cocaine and that SYN117 reduces the pleasurable response to cocaine.

Biotie Therapies signed in December 2011 a Collaborative Research and Development Agreement  with the National Institute on Drug Abuse (NIDA) at the US National Institutes of Health.

Under the agreement, NIDA and Biotie will investigate the safety and efficacy of Biotie's nepicastat in the treatment of cocaine dependence. NIDA will fund the conduct of a randomized, double-blind placebo-controlled trial, lasting 11 weeks, in 180 treatment-seeking cocaine-dependent subjects using nepicastat supplied by Biotie. The study will be conducted at approximately 12 US clinics specializing in the treatment of drug dependence.
Stock exchange release 10 May, 2013 – ‘Biotie announces start of clinical study with nepicastat (SYN117) in cocaine dependence’

Biotie and NIDA have previously collaborated on preclinical studies evaluating potential pharmacokinetic and pharmacodynamic interactions between nepicastat and drugs of abuse. Biotie retains rights to nepicastat and will be able to use data from studies conducted with NIDA to support future potential regulatory submissions.

SYN117 for PTSD

Nepicastat was also in a Phase 2 study for the treatment of PTSD that is being funded by the US Department of Defence. PTSD is a condition with significant unmet medical need and with a growing prevalence in both the civilian and military communities.

Biotie reported top-line data from clinical study with nepicastat (SYN117) in post-traumatic stress disorder in 27 December, 2012 (stock exchange release).
Treatment with nepicastat was not effective in relieving PTSD-associated symptoms when compared to placebo. Nepicastat was generally well tolerated.

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Updated 13 May, 2013