Reviva to Present New Brilaroxazine Data for Pulmonary Fibrosis at 2024 ATS Conference

Reviva Pharmaceuticals Holdings, Inc., a late-stage pharmaceutical company headquartered in Cupertino, California, has recently announced new efficacy data for its drug candidate, brilaroxazine, in an animal model of idiopathic pulmonary fibrosis (IPF). The data will be presented by Laxminarayan Bhat, Ph.D., the Founder, President, and CEO of Reviva, during a late-breaking poster session at the 2024 American Thoracic Society (ATS) International Conference, scheduled for May 17-22, 2024, in San Diego, California.

The presentation, titled "Effectiveness of brilaroxazine on functional and underlying pathological inflammation and fibrosis parameters in bleomycin-induced idiopathic pulmonary fibrosis model using male sprague dawley rats," will be showcased on Tuesday, May 21, 2024, from 9:15 am to 4:15 pm PT at the San Diego Convention Center. This session is part of the thematic poster session focusing on preclinical modeling of pulmonary inflammation and emphysema.

Brilaroxazine is a novel chemical entity discovered by Reviva, showing high affinity and selectivity for essential serotonin and dopamine receptors involved in schizophrenia and its associated symptoms. The drug has achieved significant positive results in a global Phase 3 RECOVER trial for schizophrenia, meeting all primary and secondary endpoints. The trial demonstrated statistically significant and clinically meaningful reductions in major symptom domains at week four with a 50 mg dosage of brilaroxazine, compared to a placebo. Moreover, the drug was generally well-tolerated, with a side effect profile similar to placebo and lower discontinuation rates.

Additionally, a clinical drug-drug interaction (DDI) study revealed no clinically significant interactions between brilaroxazine and a CYP3A4 inhibitor in healthy subjects. Reviva has completed a comprehensive set of regulatory-compliant toxicology and safety pharmacology studies for brilaroxazine. The company aims to develop the drug for other neuropsychiatric conditions, such as bipolar disorder, major depressive disorder (MDD), and attention-deficit/hyperactivity disorder (ADHD).

Beyond neuropsychiatric conditions, brilaroxazine has shown promising nonclinical efficacy in treating inflammatory diseases, including psoriasis, pulmonary arterial hypertension (PAH), and idiopathic pulmonary fibrosis (IPF). In translational animal models, the drug has demonstrated the ability to mitigate fibrosis and inflammation. The U.S. FDA has already granted Orphan Drug Designation to brilaroxazine for treating PAH and IPF.

Reviva Pharmaceuticals Holdings, Inc. is focused on discovering, developing, and aiming to commercialize next-generation therapeutics targeting diseases with unmet medical needs. The company's current pipeline includes two drug candidates, brilaroxazine (RP5063) and RP1208, both of which are proprietary chemical entities. Reviva has secured composition of matter patents for these compounds in the United States, Europe, and various other countries.

Reviva is committed to addressing significant medical needs in the areas of the central nervous system, respiratory, and metabolic diseases. By advancing its innovative therapeutics, the company aims to alleviate the societal and patient burdens associated with these conditions.