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July 10, 2024 — Reviva Pharmaceuticals Holdings, Inc., a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced European Patent EP3244896 has been granted by the European Patent Office (EPO) covering use of brilaroxazine for the treatment of PH, adding to its existing patent protection in key markets around the world including the United States, China and Japan. The European patent covers brilaroxazine use for treating PH and PAH in any patients and treating PH in patients with COPD or SCD. Brilaroxazine has received Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of PAH.
“This latest patent further secures the broad therapeutic potential of brilaroxazine for inflammatory conditions driven by underlying disruption in serotonin signaling like pulmonary hypertension,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO. “Brilaroxazine has demonstrated a favorable clinical safety and tolerability profile in over 800 subjects to date from multiple clinical trials. A significant reduction in key proinflammatory biomarkers following brilaroxazine treatment was recently shown in a large, global, pivotal Phase 3 study in patients with schizophrenia. Building on this promising clinical data, potent anti-inflammatory and antifibrotic activities and significant reduction in pulmonary arterial pressure has been shown in translational animal models for PAH following brilaroxazine treatment, and we look forward to further evaluating brilaroxazine’s unique multi-modal mechanism of action with clinical development expansion opportunities in PH and PAH.”
About Brilaroxazine
Brilaroxazine is an in-house discovered new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in the pathobiology of several conditions including schizophrenia, psoriasis and interstitial lung diseases like pulmonary hypertension, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF).
Positive topline data from the global Phase 3 RECOVER-1 trial in schizophrenia demonstrated the trial successfully met all primary and secondary endpoints with statistically significant and clinically meaningful reductions across all major symptom domains including reduction in key proinflammatory cytokines implicated in the pathobiology of schizophrenia and comorbid inflammatory conditions at week 4 with 50 mg of brilaroxazine vs. placebo with a generally well-tolerated side effect profile comparable to placebo and discontinuation rates lower than placebo. Positive data from a clinical drug-drug interaction (DDI) study investigating the potential effect of CYP3A4 enzyme on brilaroxazine in healthy subjects supports no clinically significant interaction when combined with a CYP3A4 inhibitor. Reviva believes that a full battery of regulatory compliant toxicology and safety pharmacology studies has been completed for brilaroxazine. Reviva intends to develop brilaroxazine for other neuropsychiatric indications including bipolar disorder, major depressive disorder (MDD) and attention-deficit/hyperactivity disorder (ADHD).
Additionally, brilaroxazine has shown promising nonclinical activity for inflammatory diseases psoriasis, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) with mitigation of fibrosis and inflammation in translational animal models. Brilaroxazine has already received Orphan Drug Designation by the U.S. FDA for the treatment of PAH and IPF conditions.
For more information: www.revivapharma.com
October 23, 2023 
