Reviva Secures U.S. Patent for Brilaroxazine in Treating Idiopathic Pulmonary Fibrosis

Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH), a pharmaceutical company focusing on developing treatments for unmet medical needs in central nervous system (CNS), inflammatory, and cardiometabolic diseases, has announced a significant development. The U.S. Patent and Trademark Office (USPTO) has granted U.S. Patent 12053477, which covers the use of brilaroxazine for treating idiopathic pulmonary fibrosis (IPF), as well as pulmonary fibrosis in patients with conditions such as chronic obstructive pulmonary disease (COPD), sickle cell anemia, scleroderma, or lung cancer. This new patent adds to the company’s existing protection in Japan. Brilaroxazine has already received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of IPF.

Dr. Laxminarayan Bhat, Founder, President, and CEO of Reviva, expressed satisfaction with the expansion of their intellectual property for brilaroxazine. He highlighted its potential to treat inflammatory conditions like IPF, which are driven by disruptions in serotonin signaling. This new patent enhances their existing intellectual property in pulmonary hypertension and aims to maximize brilaroxazine’s value in treating interstitial lung diseases.

Brilaroxazine is a novel chemical entity discovered in-house by Reviva, with strong affinity and selectivity for key serotonin and dopamine receptors involved in several conditions, including schizophrenia, psoriasis, and interstitial lung diseases like pulmonary hypertension and idiopathic pulmonary fibrosis (IPF). 

Positive topline results from the global Phase 3 RECOVER-1 trial in schizophrenia have shown that the trial met all primary and secondary endpoints. The trial demonstrated statistically significant and clinically meaningful reductions in symptoms, including key proinflammatory cytokines associated with schizophrenia and comorbid inflammatory conditions. These results were observed at week 4 with a 50 mg dose of brilaroxazine compared to placebo. The side effect profile was generally well-tolerated and comparable to placebo, with lower discontinuation rates.

Moreover, a clinical drug-drug interaction (DDI) study investigating brilaroxazine's interaction with the CYP3A4 enzyme in healthy subjects showed 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 expand the development of brilaroxazine to other neuropsychiatric conditions, including bipolar disorder, major depressive disorder (MDD), and attention-deficit/hyperactivity disorder (ADHD).

In addition to its potential in CNS disorders, brilaroxazine has shown promising nonclinical results for inflammatory diseases such as psoriasis, pulmonary arterial hypertension (PAH), and idiopathic pulmonary fibrosis (IPF). These studies have demonstrated the drug’s ability to mitigate fibrosis and inflammation in translational animal models. The U.S. FDA has already granted Orphan Drug Designation to brilaroxazine for treating PAH and IPF.

Reviva Pharmaceuticals is a late-stage biopharmaceutical company dedicated to discovering, developing, and commercializing next-generation therapeutics for diseases with significant unmet medical needs. The company's current pipeline includes two drug candidates: brilaroxazine (RP5063) and RP1208. Both are new chemical entities discovered by Reviva and have received composition of matter patents in the United States, Europe, and several other countries. Reviva’s work aims to address the burdens these diseases pose on society, patients, and their families.

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