Pharma Focus Asia

Reviva Pharmaceuticals Receives European Patent for Brilaroxazine in Treating Pulmonary Hypertension

Thursday, July 11, 2024

Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) announced today that it has been granted European Patent EP3244896 by the European Patent Office (EPO) for the use of brilaroxazine in treating pulmonary hypertension (PH). This patent adds to Reviva's existing global patent protection in key markets, including the United States, China, and Japan. Brilaroxazine, which has also received Orphan Drug Designation from the FDA for pulmonary arterial hypertension (PAH), demonstrates potential in treating PH across various patient groups, including those with COPD or sickle cell disease (SCD).

Reviva, highlighted that this new patent enhances brilaroxazine's therapeutic potential for inflammatory conditions linked to disruptions in serotonin signaling, such as PH. Brilaroxazine has shown positive clinical safety and tolerability profiles in extensive trials involving over 800 subjects. Recent Phase 3 studies in schizophrenia demonstrated significant reductions in proinflammatory biomarkers, supporting its anti-inflammatory and antifibrotic activities observed in animal models of PAH.

Brilaroxazine, a novel compound discovered in-house by Reviva, targets serotonin and dopamine receptors implicated in conditions like schizophrenia, psoriasis, and interstitial lung diseases such as PAH and idiopathic pulmonary fibrosis (IPF). Its successful Phase 3 RECOVER-1 trial in schizophrenia achieved all primary and secondary endpoints, with notable reductions in major symptom domains and cytokine levels compared to placebo. Further clinical development is planned for indications like bipolar disorder, major depressive disorder (MDD), and attention-deficit/hyperactivity disorder (ADHD).

Reviva's comprehensive development strategy includes regulatory compliant toxicology and safety studies, reinforcing brilaroxazine's potential across neuropsychiatric and inflammatory disease indications.



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