Reviva Updates Enrollment for Brilaroxazine Schizophrenia Study

Reviva Pharmaceuticals Holdings, Inc., a company specializing in advanced-stage pharmaceutical research, has provided an update on the enrollment for its 1-year open-label extension (OLE) study. The study evaluates the long-term safety and tolerability of brilaroxazine in patients with schizophrenia. The study is being conducted across multiple sites in the United States, Europe, and Asia.

As of mid-May 2024, the study has successfully enrolled 358 patients with 223 patients currently undergoing treatment. The study has seen significant progress with over 90 patients having completed 6 to 9 months of treatment and 23 patients having successfully completed a full year of treatment. Dr. Laxminarayan Bhat, Founder, President, and CEO of Reviva, expressed satisfaction with the enrollment pace and emphasized the importance of gathering long-term safety data from 100 patients who have completed one year of treatment. This data is crucial for their planned New Drug Application (NDA) submission to the FDA, expected in the fourth quarter of 2025. So far, brilaroxazine has shown a favorable tolerability profile in patients with acute and stable schizophrenia.

The RECOVER Trial OLE involves a randomized, double-blind, placebo-controlled, multicenter study. This study is designed to assess the efficacy and safety of brilaroxazine at fixed doses of 15 mg or 50 mg, administered once daily for 28 days in subjects experiencing an acute exacerbation of schizophrenia. This is followed by a long-term safety assessment of brilaroxazine at flexible doses of either 15, 30, or 50 mg administered once daily for 52 weeks in subjects with stable schizophrenia. The study includes both double-blind rollover and de novo subjects with stable schizophrenia.

Brilaroxazine, discovered in-house by Reviva, is a new chemical entity that exhibits strong affinity and selectivity for key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms. The global Phase 3 RECOVER-1 trial produced positive topline data, successfully meeting all primary and secondary endpoints. The results showed statistically significant and clinically meaningful reductions across all major symptom domains at week 4 with 50 mg of brilaroxazine compared to placebo. The side effect profile was generally well-tolerated, with discontinuation rates lower than those for placebo.

Additional data from a drug-drug interaction study revealed no clinically significant interaction between brilaroxazine and a CYP3A4 inhibitor, suggesting a good safety profile. The company has completed a comprehensive set of regulatory-compliant toxicology and safety pharmacology studies for brilaroxazine. Reviva aims to develop brilaroxazine further for other neuropsychiatric conditions, including bipolar disorder, major depressive disorder (MDD), and attention-deficit/hyperactivity disorder (ADHD).

Beyond its potential in neuropsychiatric conditions, brilaroxazine has shown promising nonclinical activity in treating inflammatory diseases such as psoriasis, pulmonary arterial hypertension (PAH), and idiopathic pulmonary fibrosis (IPF). The compound has demonstrated the ability to mitigate fibrosis and inflammation in animal models. The U.S. FDA has granted Orphan Drug Designation for brilaroxazine in treating PAH and IPF.

Reviva Pharmaceuticals remains committed to discovering, developing, and commercializing next-generation therapeutics to address unmet medical needs. Their current pipeline focuses on central nervous system (CNS), inflammatory, and cardiometabolic diseases. In addition to brilaroxazine, Reviva is developing RP1208, another new chemical entity discovered in-house. Both drug candidates have received composition of matter patents in the United States, Europe, and several other countries.