Reviva Pharmaceuticals, Inc., (Reviva), a privately held drug discovery and development company, today announces top-line results from REFRESH, a phase 2 clinical trial of RP5063 for the treatment of schizophrenia and schizoaffective disorder. REFRESH is a randomized, double-blind, placebo-controlled, dose ranging, global and multi-center phase 2 study to assess the efficacy, safety and tolerability of RP5063 in male and female patients with schizophrenia. A total of 234 schizophrenia patients were enrolled from USA, Asia and Europe in this phase 2 study (for more details please visit: www.clinicaltrials.gov and identifier: NCT01490086). These top-line results will be followed with more details following completion of the data analysis at New Clinical Drug Evaluation Unit (NCDEU) annual meeting on May 28-31, 2013. An earlier Phase 1b trial had been conducted in patients with stable schizophrenia in the United States reported at NCDEU 2012.
“These results confirm that the dopamine serotonin stabilizer, RP5063, has great promise, since it is both effective and with a potentially excellent safety profile, particularly with regards to metabolic problems”
Patients with acute exacerbation of schizophrenia or schizoaffective disorder were randomized to be treated for a month with either RP5063 at doses of 15 mg, 30 mg, or 50 mg/day or placebo or a control arm of aripiprazole (15 mg). RP5063 showed overall broad efficacy across the Positive and Negative Syndrome Scale (PANSS) total scores as well as subscales: Positive, Negative and General Psychopathology. RP5063 also showed efficacy in the Clinical Global Impression Severity (CGI-S) Scale further strengthening the efficacy shown in the PANSS.
In this REFRESH trial; RP5063 was well-tolerated with a very favorable safety profile as demonstrated in the earlier trial. There were no clinically important differences in systematic side effects between RP5063 and placebo, including motor function (movement) side effects, cardiac, metabolic parameters, or in prolactin related sexual problems, which are common side effect of current antipsychotic treatments. Laboratory testing revealed no clinically significant changes in normal blood chemistries, hematology or urine parameters.
"These results confirm that the dopamine serotonin stabilizer, RP5063, has great promise, since it is both effective and with a potentially excellent safety profile, particularly with regards to metabolic problems," said Oliver Freudenreich, MD, Director of Schizophrenia Program at Massachusetts General Hospital and Associate Professor at Harvard Medical School.
"These results confirm that RP5063 promises to be a 'best in class' dopamine serotonin stabilizer that has the potential to improve the treatment of schizophrenia and schizoaffective disorder, filling a much unmet medical need. The favorable tolerability data also lends support to trials in even more fragile populations, such as geriatrics and pediatrics," said study investigator Mark Novitsky, MD, Principal Investigator, CRI Lifetree Philadelphia Research Center.
Reviva Pharmaceuticals Inc.