Bionomics (ASX:BNO), a company focused on the discovery and development of innovative therapeutics for the treatment of diseases of the central nervous system and cancer, has initiated a Phase 2 clinical trial with its drug candidate BNC210 in adults suffering Post Traumatic Stress Disorder (PTSD).
The company said the study’s primary objective is to determine whether BNC210 causes a decrease in symptoms of PTSD as measured by the globally-accepted Clinician-Administered PTSD Scale (CAPS-5). Secondary objectives include the determination of the effects of BNC210 on anxiety, depression, quality of life, and safety.
This clinical study will recruit 160 subjects with PTSD at 8-10 clinical research centres throughout Australia and New Zealand. The study is a randomised, double-blind, placebo-controlled design with subjects to be treated over 12 weeks with BNC210 or placebo. The Principal Investigator is Professor Jayashri Kulkarni from the Monash Alfred Psychiatry Research Centre in Melbourne, Australia.
According to Bionomics, PTSD is very common and its societal and economic burden extremely heavy.
"It is estimated that 5-10% of the general population will suffer from PTSD at some point in their lives," it said. "Currently, only two drugs, the antidepressants paroxetine and sertraline, are approved for the treatment of PTSD. However, they have not been shown to ameliorate the full range of PTSD symptoms, and complete remission of symptoms is rare."
Bionomics said it has also recently completed recruitment to a Phase 2 clinical study examining the biological effects of BNC210 on the brain, in subjects with Generalised Anxiety Disorder (GAD). The results of this study will be known in Q3 2016.