Reviva Pharmaceuticals Announces Enrollment of Patients in Phase 2 Clinical Study of RP5063 for the Treatment of Schizophrenia and Schizoaffective Disorder

SAN JOSE, Calif.--(BUSINESS WIRE)--

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.

About Schizophrenia and Schizoaffective Disorder

Schizophrenia is a serious lifelong mental disease whose symptoms are generally divided into three categories - Positive, Negative, and Cognitive. Major positive symptoms are delusions, hallucinations, disordered thoughts and speech. Negative symptoms commonly include emotional flatness or lack of expression, an inability to start and follow through with activities, speech that is brief and devoid of content, and a lack of pleasure or interest in life. Cognitive Symptoms are across multiple domains including inattention and poor memory. Many schizophrenia patients also suffer from depression and mood swings and some even bipolar-like states as schizoaffective disorder. Current antipsychotics may help relieve the positive symptoms of schizophrenia but are poorly effective for treating negative and cognitive symptoms. Approved pharmacological treatments have dose limiting side effects, including troublesome actions on motor function (movement), weight gain, and metabolic symptoms (diabetes and hyperlipidemia), diminished sexual function, sedation, constipation, dizziness, and loss of bladder control. Many patients do not take their prescribed medications due to the side effects. Few patients are able to regain normal psychosocial function with currently available pharmacological and rehabilitation treatments. Therefore, the unmet need for a safer and more effective alternative treatment for schizophrenia and schizoaffective disorder is enormous.

About RP5063

RP5063 is an orally active new chemical entity (NCE) with potent dopamine D₂/serotonin 5-HT_1A partial agonist and D₃/D₄ antagonist activity. RP5063 has a low potency at other receptor sites such as 5-HT_2C, muscarinic and adrenergic receptor. RP5063 is also under development for the treatment of Bipolar Disorders including acute mania, mood disorders including Major Depressive Disorder (MDD) and Tourette's syndrome. The patent life of RP5063 is effective until February 2029.

About Reviva Pharmaceuticals Inc

Reviva Pharmaceuticals Inc. (Reviva), located in San Jose, California, is an emerging clinical stage pharmaceutical company focused on developing a portfolio of internally discovered next generation safe and effective therapeutic drugs by using an integrated chemical genomics-based technology platform and proprietary chemistries. Reviva is currently focused on developing best in class new drugs for the central nervous system (CNS), metabolic, cardiovascular (CV), inflammation and pain indications.

Reviva's leadership team has a strong background and a track record in successful rapid product development, regulatory approval and commercialization. Reviva was founded in 2006 and financed by angel investors including medical doctors, successful entrepreneurs, and professionals associated with the pharmaceutical and high-tech industries. For additional information, please visit our website at www.revivapharma.com.

Forward Looking Statements

This press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events, they give no assurance that such expectations will prove to be correct. Forward-looking statements are subject to a number of risks and uncertainties, but not limited to, our liability to obtain additional capital on acceptable terms, or at all, including additional capital which will be necessary to complete the clinical trials, the availability of top-line-data-delays in enrollment, delays caused by institutional review boards or regulatory agencies, shortage of clinical trial supplies, dependence on clinical trial collaborators, loss of any executive officers or key personnel or consultants. Undue reliance should be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Reviva disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.