Reviva Secures European Patent for Brilaroxazine in Pulmonary Fibrosis Treatment
Key Insights
Reviva Pharmaceuticals received European Patent 3749324 covering brilaroxazine use for treating pulmonary fibrosis (search), including idiopathic pulmonary fibrosis (search) (IPF).
The patent adds to existing intellectual property protection in key markets including the United States, China, and Japan for this novel serotonin-targeting therapy.
Brilaroxazine has already received FDA Orphan Drug Designation for IPF treatment and demonstrated promising preclinical activity with mitigation of fibrosis and inflammation in animal models.
Reviva Pharmaceuticals Holdings (search), Inc. (NASDAQ: RVPH) announced that the European Patent Office (search) (EPO) has granted European Patent 3749324 covering the use of brilaroxazine for treating pulmonary fibrosis (search), including idiopathic pulmonary fibrosis (search) (IPF). This patent strengthens the company's global intellectual property portfolio, joining similar patents already granted in the United States, China, and Japan.
The late-stage pharmaceutical company's brilaroxazine represents a novel therapeutic approach targeting the underlying disruption in serotonin signaling implicated in pulmonary fibrosis (search) pathogenesis. The drug has already received Orphan Drug Designation from the U.S. Food and Drug Administration (search) for IPF treatment.
Novel Mechanism Addresses Unmet Medical Need
Brilaroxazine is an in-house discovered new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors (search). The compound targets pathophysiology implicated in several conditions including schizophrenia (search), psoriasis (search), and interstitial lung diseases like pulmonary hypertension, pulmonary arterial hypertension (search) (PAH), and idiopathic pulmonary fibrosis (search).
"Securing this latest patent further strengthens our intellectual property portfolio and underscores the broad therapeutic relevance of brilaroxazine's unique mechanism of action in chronic fibrotic disorders like pulmonary fibrosis (search) or IPF," said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva.
Strong Clinical Foundation Supports Expansion
The company's confidence in expanding brilaroxazine development stems from positive results in schizophrenia (search) trials. The global Phase 3 RECOVER trial successfully met all primary and secondary endpoints with statistically significant and clinically meaningful reductions across all major symptom domains. At week 4, patients receiving 50 mg of brilaroxazine versus placebo showed reduction in key proinflammatory cytokines implicated in schizophrenia pathophysiology and comorbid inflammatory conditions.
The drug demonstrated a generally well-tolerated side effect profile comparable to placebo, with discontinuation rates lower than placebo. Additional clinical drug-drug interaction studies investigating CYP3A4 (search) enzyme effects showed no clinically significant interaction when combined with CYP3A4 inhibitors.
Preclinical Promise in Fibrotic Diseases
Beyond clinical validation in psychiatric indications, brilaroxazine has shown promising nonclinical activity for inflammatory diseases including psoriasis (search), pulmonary arterial hypertension (search), and idiopathic pulmonary fibrosis (search). In translational animal models, the compound demonstrated mitigation of both fibrosis and inflammation.
The FDA has already granted Orphan Drug Designation for brilaroxazine in treating both PAH and IPF conditions, recognizing the significant unmet medical need in these rare diseases.
Strategic Development Pipeline
Bhat emphasized the strategic value of the company's position: "With a late-stage asset that in our trials has been well-tolerated across large patient populations, we are poised to further expand clinical development from schizophrenia (search) into additional high-value indications with the potential for multiple paths to value creation for our brilaroxazine program."
Reviva plans to develop brilaroxazine for additional neuropsychiatric indications including bipolar disorder (search), major depressive disorder (search), and attention-deficit/hyperactivity disorder (search). The company believes it has completed a full battery of regulatory compliant toxicology and safety pharmacology studies for brilaroxazine.
The biopharmaceutical company focuses on discovering, developing, and commercializing next-generation therapeutics for diseases representing unmet medical needs in central nervous system, inflammatory, and cardiometabolic diseases. Reviva's current pipeline includes two drug candidates: brilaroxazine (RP5063) and RP1208, both new chemical entities discovered in-house with composition of matter patents granted in the United States, Europe, and several other countries.