Reviva Pharmaceuticals has announced positive data from a Phase II trial of RP5063 to treat schizophrenia and schizoaffective disorder.
The randomised double-blind study was designed to evaluate RP5063’s efficacy, safety and tolerability profile in male and female schizophrenia patients.
Massachusetts General Hospital schizophrenia programme director and Harvard Medical School associate professor Dr Oliver Freudenreich said; "These results confirm that the dopamine serotonin stabiliser RP5063 has great promise since it is both effective and with a potentially excellent safety profile particularly with regards to metabolic problems."
The placebo-controlled, dose ranging, multi-centre study enrolled a total of 234 schizophrenia patients from the US, Asia and Europe.
Patients were randomised to receive either RP5063 at doses of 15mg, 30mg or 50mg/day, placebo or a control arm of aripiprazole (15mg).
Overall broad efficacy of the candidate was established across the Positive and Negative Syndrome Scale total scores, in addition to subscales for Positive Negative and General Psychopathology.
An efficacy in the Clinical Global Impression Severity Scale was also noted.
RP5063 was well-tolerated with favourable safety profile in the study.
Clinically vital differences in systematic side effects between RP5063 and placebo such as motor function, cardiac metabolic parameters or in prolactin-related sexual problems were not identified.
No change was observed in normal blood chemistries haematology or urine parameters.
CRI Lifetree Philadelphia Research Center principal investigator Dr Mark Novitsky said; "These results confirm that RP5063 promises to be a ‘best in class’ dopamine serotonin stabiliser that has the potential to improve the treatment of schizophrenia and schizoaffective disorder filling a much unmet medical need."