Reviva Pharmaceuticals 将在生物精神病学学会第 78 届年度科学大会上展示新型血清素-多巴胺稳定剂 Brilaroxazine

Reviva Pharmaceuticals Holdings, Inc. (Nasdaq: RVPH) ("Reviva" or the "Company"), a clinical-stage pharmaceutical company developing drugs designed to address central nervous system (CNS), respiratory and metabolic diseases, today announced that Dr. Laxminarayan Bhat, Reviva founder, president and CEO, will present a poster at the 78th Annual Scientific Meeting of Biological Psychiatry 2023 in San Diego, California, April 27-29. Details of the poster presentation are as follows: Brilaroxazine (RP5063) is a novel serotonin-dopamine stabilizer that exhibits antipsychotic effects in rodents.

Brilaroxazine (RP5063) is a novel serotonin-dopamine stabilizer that exhibits antipsychotic effects in rodents.

Brilaroxazine is a new chemical entity with strong affinity and selectivity for key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms. In a multinational, multicenter, double-blind Phase 2 study of 234 patients with acute schizophrenia or schizoaffective disorder, iloxazine met its primary endpoint, reducing positive and negative syndrome scale (PANSS) total scores and demonstrating that use of the drug significantly improved overall medication outcomes on the Clinical Global Impression (CGI) scale and secondary endpoints assessing social functioning, positive and negative symptoms, and directed improvements in depression and cognition. In this completed Phase 2 study, brilaroxazine met all safety endpoints, with no weight gain, no increase in blood glucose or lipids, and no cardiac or endocrine adverse effects compared with placebo. Positive data from a clinical drug-drug interaction (DDI) study investigating the potential effects of CYP3A4 enzymes on iloxazine in healthy subjects indicate the absence of clinically significant interactions when coadministered with a CYP3A4 inhibitor. A series of regulatory-compliant toxicology and safety pharmacology studies have been completed for brilaroxazine. The U.S. Food and Drug Administration (FDA) has agreed to consider a potential superior safety label claim if positive results emerge on relevant endpoints in a pivotal Phase 3 study in patients with schizophrenia. Reviva intends to develop iloxadine for other neuropsychiatric indications, including bipolar disorder, major depressive disorder (MDD) and attention-deficit/hyperactivity disorder (ADHD).

Furthermore, brilaroxazine has shown promising efficacy in alleviating pulmonary fibrosis and inflammation in pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) in translational animal models. Reviva believes brilaroxazine has the potential to slow disease progression in PAH and IPF and intends to develop brilaroxazine for these pulmonary indications. Brilaroxazine has received Orphan Drug Designation from the U.S. FDA for the treatment of these diseases.