Reviva to initiate enrollment in RP503 phase 2 study for schizophrenia

Mar 13 2012

Reviva Pharmaceuticals, Inc., a privately held drug discovery and development company, today announced enrollment of patients in its phase 2 clinical study of RP503 for schizophrenia and schizoaffective disorder. The purpose of this randomized, double-blind, placebo-controlled, four-arm, global multi-center Phase 2 study is to assess the efficacy, safety and tolerability of RP5063 in male and female patients with schizophrenia. The trial plans to enroll 228 patients from USA, India, Philippines, Malaysia and Russia. The company expects to report results of this Phase 2 clinical study for RP5063 towards the end of this year.

Results from the Phase 1 clinical study of RP5063 conducted in the United States in 55 Caucasian and Asian subjects, both healthy volunteers and schizophrenia patients indicated that drug is well-tolerated with a very favorable safety profile, predictable pharmacokinetics suited for once-daily oral dosing schedule. The 32-patient Phase 1b multiple ascending dose (MAD) trial showed good acceptance by subjects as well as activity in disease stabilization and cognition. The most frequent adverse event was mild to moderate nausea, but no patient dropped out of the trial due to side effects. On the Positive and Negative Syndrome Scale (PANSS), there was an overall a significant effect for treatment vs. placebo for the Positive Factor Score. Furthermore, there were also favorable trends in other symptoms such as anxiety/depression and impulsivity/hostility.

Neuropsychologist Dr. John Harrison commented "These results suggest that RP5063 may have the propensity to benefit executive function and, in contrast to older antipsychotics, is thus far free of any cognitive adverse effects."

Reviva will present the Phase 1 study safety, pharmacokinetics (PK) and efficacy results at the New Clinical Drug Evaluation Unit (NCDEU) conference on May 29-June 1, 2012 in Phoenix, Arizona.