Reviva Unveils New Vocal Biomarker Data from Phase 3 Brilaroxazine Schizophrenia Trial

Reviva Pharmaceuticals Holdings Inc., a late-stage pharmaceutical company, recently shared promising vocal biomarker data from its Phase 3 RECOVER trial focused on brilaroxazine for treating schizophrenia. This announcement was made during a virtual key opinion leader event hosted by the company on September 4, 2024. The event featured prominent figures such as Dr. Brian Kirkpatrick from the University of Arkansas for Medical Sciences and Dr. Mark Opler from the PANSS Institute in New York.

The new data highlight brilaroxazine’s efficacy in addressing negative symptoms and other key symptom domains of schizophrenia, demonstrated through statistically significant vocal biomarker speech latency results. This vocal biomarker acts as an objective tool, reinforcing the primary and secondary endpoints evaluated in the RECOVER trial. According to Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva, these findings validate the broad-spectrum efficacy of brilaroxazine, which includes negative symptoms. Dr. Brian Kirkpatrick echoed these sentiments, emphasizing that the objective vocal biomarker data confirm robust treatment effects across various symptom domains, including social function and disorganization.

The key highlights of the vocal biomarker data include the emergence of speech latency as an objective tool for validating assessments made by human raters. Brilaroxazine has shown strong efficacy for negative symptoms and other key schizophrenia symptoms such as total and positive symptoms, disorganization, and social functioning in the pivotal Phase 3 RECOVER trial. The statistically significant results of the vocal biomarker speech latency analysis further support the strong efficacy of brilaroxazine.

Dr. Mark Opler from WCG Inc. highlighted the challenges with current schizophrenia treatments, which often fail to address critical aspects like negative symptoms and cognition. Moreover, the poor tolerability of existing antipsychotics leads to low treatment adherence and high discontinuation rates. In contrast, brilaroxazine has shown consistent efficacy across multiple domains coupled with a very favorable efficacy-to-side-effect ratio, indicating its potential to meet significant unmet needs in schizophrenia treatment.

Brilaroxazine is a new chemical entity discovered in-house by Reviva, designed to target key serotonin and dopamine receptors implicated in conditions such as schizophrenia, psoriasis, and interstitial lung diseases like pulmonary hypertension and idiopathic pulmonary fibrosis (IPF). The Phase 3 RECOVER trial demonstrated that brilaroxazine met all primary and secondary endpoints, showing significant reductions in major symptom domains and key proinflammatory cytokines at week 4 with a 50 mg dose. The treatment was generally well-tolerated, with discontinuation rates lower than placebo.

Positive data from a clinical drug-drug interaction study suggest no significant interaction between brilaroxazine and CYP3A4 inhibitors, supporting its safety profile. Reviva plans to develop brilaroxazine for other neuropsychiatric conditions, including bipolar disorder, major depressive disorder, and attention-deficit/hyperactivity disorder.

Additionally, brilaroxazine has shown promising nonclinical activity for inflammatory diseases like psoriasis, pulmonary arterial hypertension (PAH), and IPF, mitigating fibrosis and inflammation in animal models. The drug has already received Orphan Drug Designation from the U.S. FDA for treating PAH and IPF.

Reviva Pharmaceuticals is focused on discovering, developing, and commercializing next-generation therapeutics for diseases that present unmet medical needs. Its pipeline includes brilaroxazine and RP1208, both new chemical entities discovered in-house, with patents granted in the United States, Europe, and other countries. The company continues to prioritize the development of treatments for central nervous system, inflammatory, and cardiometabolic diseases.