Reviva Granted European Patent for Brilaroxazine in Pulmonary Hypertension Treatment

Reviva Pharmaceuticals Holdings, Inc., a biopharmaceutical company focused on addressing unmet medical needs in central nervous system (CNS), inflammatory, and cardiometabolic diseases, has announced the granting of European Patent EP3244896 by the European Patent Office. This patent covers the use of brilaroxazine for treating pulmonary hypertension (PH) and pulmonary arterial hypertension (PAH). The patent extends to treating PH in patients with chronic obstructive pulmonary disease (COPD) or sickle cell disease (SCD). Brilaroxazine has similar patent protections in key markets including the United States, China, and Japan.

Brilaroxazine, an innovative chemical entity discovered by Reviva Pharmaceuticals, shows potent affinity and selectivity for serotonin and dopamine receptors, which play a role in the pathobiology of various conditions such as schizophrenia, psoriasis, and interstitial lung diseases like PH, PAH, and idiopathic pulmonary fibrosis (IPF). The compound has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of PAH.

Dr. Laxminarayan Bhat, Founder, President, and CEO of Reviva, emphasized the broad therapeutic potential of brilaroxazine, particularly for inflammatory conditions stemming from disruptions in serotonin signaling, such as pulmonary hypertension. Dr. Bhat highlighted that brilaroxazine has demonstrated a favorable safety and tolerability profile in more than 800 subjects across multiple clinical trials. Recent findings from a large global Phase 3 study in schizophrenia showed significant reductions in key proinflammatory biomarkers following brilaroxazine treatment. In addition, translational animal models for PAH displayed potent anti-inflammatory, antifibrotic activities, and a significant reduction in pulmonary arterial pressure with brilaroxazine.

Brilaroxazine has shown promising data from the global Phase 3 RECOVER-1 trial in schizophrenia, successfully meeting all primary and secondary endpoints. The trial demonstrated statistically significant and clinically meaningful reductions across major symptom domains, including proinflammatory cytokines related to schizophrenia and comorbid inflammatory conditions. The drug exhibited a side effect profile comparable to placebo and had lower discontinuation rates.

Additionally, a clinical drug-drug interaction study on the potential effect of the CYP3A4 enzyme on brilaroxazine in healthy subjects indicated no clinically significant interaction when combined with a CYP3A4 inhibitor. Reviva has completed a comprehensive set of regulatory-compliant toxicology and safety pharmacology studies for brilaroxazine. The company plans to develop brilaroxazine for other neuropsychiatric conditions such as bipolar disorder, major depressive disorder (MDD), and attention-deficit/hyperactivity disorder (ADHD).

Beyond neuropsychiatric indications, brilaroxazine has shown promising nonclinical results for inflammatory diseases like psoriasis, PAH, and IPF, with evidence of reduced fibrosis and inflammation in translational animal models. The drug has already received Orphan Drug Designation from the U.S. FDA for PAH and IPF.

Reviva Pharmaceuticals, a late-stage biopharmaceutical company, focuses on developing next-generation therapeutics to address unmet medical needs. The company's pipeline includes brilaroxazine (RP5063) and RP1208, both novel chemical entities discovered in-house. Reviva holds composition of matter patents for these compounds in the United States, Europe, and other countries. The company's efforts are aimed at addressing significant medical burdens and improving the lives of patients and their families.