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Reviva announces the grant of a European patent for the use of brilaroxazine for the treatment of pulmonary hypertension

Reviva announces the grant of a European patent for the use of brilaroxazine for the treatment of pulmonary hypertension
Reviva announces the grant of a European patent for the use of brilaroxazine for the treatment of pulmonary hypertension

July 10, 2024 – Reviva Pharmaceuticals Holdings, Inc., a late-stage pharmaceutical company developing therapies that address unmet medical needs in central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced that the European Patent Office (EPO) has granted European patent EP3244896 for the use of brilaroxazine for the treatment of PH, expanding existing patent protection in key markets worldwide, including the United States, China and Japan. The European patent covers the use of brilaroxazine for the treatment of PH and PAH in all patients, as well as for the treatment of PH in patients with COPD or SCD. Brilaroxazine has received orphan drug designation from 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 diseases caused by an underlying impairment in serotonin signaling, such as 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 in multiple clinical trials to date. Significant reductions in key pro-inflammatory biomarkers following treatment with brilaroxazine were recently demonstrated in a large, global, pivotal Phase 3 study in patients with schizophrenia. Building on these promising clinical data, potent anti-inflammatory and antifibrotic activities as well as significant reductions in pulmonary arterial pressure have been demonstrated in translational animal models of PAH following treatment with brilaroxazine, and we look forward to further exploring brilaroxazine’s unique multimodal mechanism of action with opportunities to expand clinical development in PH and PAH.”

About Brilaroxazine
Brilaroxazine is an internally discovered new chemical entity with strong affinity and selectivity for key serotonin and dopamine receptors involved in the pathobiology of several diseases, including schizophrenia, psoriasis, and interstitial lung diseases such as pulmonary hypertension, pulmonary arterial hypertension (PAH), and idiopathic pulmonary fibrosis (IPF).

Positive topline data from the global Phase 3 RECOVER-1 study in schizophrenia demonstrated that the study successfully met all primary and secondary endpoints, with statistically significant and clinically meaningful reductions in all key symptom domains, including reductions in key pro-inflammatory cytokines involved in the pathobiology of schizophrenia and comorbid inflammatory diseases, at Week 4 with brilaroxazine 50 mg compared to placebo, with an overall well-tolerated side effect profile comparable to placebo and lower discontinuation rates than placebo. Positive data from a clinical drug interaction (DDI) study evaluating the potential effect of the CYP3A4 enzyme on brilaroxazine in healthy subjects do not support a clinically significant interaction when combined with a CYP3A4 inhibitor. Reviva believes that a full range of regulatory-compliant toxicology and safety pharmacology studies have 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).

In addition, brilaroxazine has shown promising nonclinical activity in inflammatory diseases such as psoriasis, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF), alleviating fibrosis and inflammation in translational animal models. Brilaroxazine has already received orphan drug designation from the US FDA for the treatment of PAH and IPF diseases.

For more information: www.revivapharma.com

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