Reviva Pharmaceuticals has completed the patient enrolment in the Phase II clinical trial of RP5063 for the treatment of schizophrenia and schizoaffective disorder.
The orally-active new chemical entity RP5063 is a dopamine-serotonin system stabiliser with a potent partial agonist activity at the dopamine D2, D3 and D4, and serotonin 5-HT1A and 5-HT2A receptors, and antagonist activity at the serotonin 5-HT6 and 5-HT7 receptors.
Reviva Pharmaceuticals president and chief executive officer Dr Laxminarayan Bhat said schizophrenia is a devastating mental disease with much unmet treatment need.
"We are optimistic that the results of this trial will establish clinical proof of concept on safety and efficacy to reveal RP5063 as a promising therapeutic option for treating schizophrenia and schizoaffective disorder," Bhat added.
The Phase II study is a randomised, double-blind, global multi-centre trial designed to assess the efficacy safety and tolerability profile of RP5063 in male and female patients with schizophrenia.
A placebo-controlled, four-arm study enrolled a total of 234 schizophrenia patients from the US, Asia and Europe.
The company expects to release the top-line results from the trial by the end of February 2013.
RP5063 is also being developed for the treatment of brain disorders as from major depressive disorder, manic-depressive bipolar disorder, psychosis in Parkinson's and Alzheimer's diseases, autism and Tourette's syndrome.