SANTA CLARA, Calif.--(BUSINESS WIRE)--Reviva Pharmaceuticals, Inc. (Reviva), a privately held, clinical stage pharmaceutical company, presented positive preclinical efficacy data for RP5063 in pulmonary arterial hypertension at the American Thoracic Society Conference in San Francisco, May 13-18, 2016. RP5063 demonstrated promising efficacy for treating pulmonary arterial hypertension (PAH) in a monocrotaline (MCT) and a sugen-hypoxia (SuHx) induced PAH rat model, both of which are gold standard animal models for evaluating efficacy for PAH. RP5063 lowered mean pulmonary arterial pressure, decreased respiratory resistance and brought the blood oxygen level to normal. Histopathology of the animals on these studies demonstrated that RP5063 significantly reduced pulmonary arterial vessels wall thickness and muscular tissue. RP5063 is a potent inhibitor of serotonin 5-HT2B receptor, a novel target for treating PAH.
“RP5063 novel mechanism of action and demonstrated preclinical proof-of-concept for PAH with functional and structural benefits are very encouraging,” stated Laxminarayan Bhat, PhD, Founder and Chief Executive Officer of Reviva Pharmaceuticals. “We would like to pursue an Orphan Drug designation for RP5063 with the FDA for the treatment PAH.”
Marc Cantillon, MD, Reviva’s Chief Medical Officer, commented: “Significant number of PAH patients also suffer from mental disorders such as psychosis, depression and anxiety. RP5063’s receptor binding profile has the potential to treat both PAH and any comorbid mental disorders which will make RP5063 especially beneficial in these patient populations.”
About Pulmonary Arterial Hypertension
PAH is a progressive life-threatening disease characterized by elevated blood pressure in the pulmonary arteries due to severe constriction of the blood vessels in the lungs and as a result, make it difficult for the heart to pump blood through the lungs to be oxygenated. Patients with PAH typically develop significant increases in pulmonary vascular resistance (PVR) and sustained elevations in pulmonary artery pressure (PAP), which ultimately leads to right ventricular failure and death. According to recent reports, over 35% of the pulmonary hypertension patients also suffer from mental disorders, with the most common being major depressive disorder and panic disorder. The prevalence of mental disorders in patients with pulmonary hypertension increased significantly with functional impairment. Based on data from the Registry to EValuate Early And Long-term PAH disease management (REVEAL) of patients in the United States, there is an estimated five-year survival rate of 57% from diagnosis. There is no cure for PAH, and the current treatments only reduce symptoms whilst some of them delay disease progression. Phosphodiesterase-5 (PDE-5) inhibitors, prostacyclins, and endothelin receptor antagonists are currently the widely used approved treatments for PAH.
RP5063 is a novel dopamine-serotonin modulator currently in clinical development for schizophrenia. RP5063 is an orally active new chemical entity (NCE) having patent exclusivity until September 2030 with possibility of patent term extension up to an additional 5 years. RP5063 global phase 2 clinical trial results showed robust efficacy with remission in acute schizophrenia in addition to promising efficacy signals for comorbid conditions such as cognition impairment and mood disorders. RP5063 showed an excellent safety and tolerability profile when compared to placebo with no weight gain, metabolic, cardiac or movement side effects, leading to good acceptance and compliance. RP5063 is also under development for the treatment of major depressive disorder (MDD), bipolar disorder, attention-deficit/hyperactivity disorder (ADHD), behavioral disorders in Alzheimer’s (BPSD) and psychosis in Parkinson’s diseases.
About Reviva Pharmaceuticals Inc.
Reviva Pharmaceuticals Inc. (Reviva), located in Santa Clara, California, is a clinical stage pharmaceutical company focused on developing a portfolio of internally discovered next generation therapies that address unmet medical needs in the areas of central nervous system (CNS) and metabolic diseases. Reviva has a strong patent portfolio and several products in the pipeline at various stages of development.
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, family offices and hedge funds. 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.