Reviva Announces Publication on Clinical Vocal Biomarker Data from the RECOVER Phase 3 Clinical Trial of Brilaroxazine to Treat Negative Symptoms in Schizophrenia

Core Insights - Reviva Pharmaceuticals announced the publication of findings from the RECOVER Phase 3 trial, highlighting the efficacy of brilaroxazine in treating schizophrenia, particularly its impact on negative symptoms and other symptom domains [1][2] - The study emphasizes the use of speech latency as a novel biomarker that can enhance clinical trial outcomes by improving patient stratification and reducing sample sizes [2][4] Company Overview - Reviva Pharmaceuticals is a late-stage biopharmaceutical company focused on developing therapies for unmet medical needs in central nervous system (CNS), inflammatory, and cardiometabolic diseases [9] - The company's pipeline includes brilaroxazine and another candidate, RP1208, both of which are new chemical entities discovered in-house [9] Clinical Trial Findings - The RECOVER Phase 3 trial successfully met all primary and secondary endpoints, showing statistically significant reductions in major symptom domains, including negative symptoms, with a 50 mg dose of brilaroxazine compared to placebo [6] - Brilaroxazine demonstrated a well-tolerated side effect profile, with discontinuation rates lower than those observed in the placebo group [6] Biomarker Insights - Speech latency, an objective measure of verbal response time, effectively differentiates between patients with moderate-to-severe and low negative symptoms across various demographics [4][7] - VBM-positive patients exhibited a strong treatment response to brilaroxazine, particularly in negative symptoms, as assessed by clinician evaluations [7] Future Development - Reviva plans to explore brilaroxazine for additional neuropsychiatric indications, including bipolar disorder, major depressive disorder (MDD), and attention-deficit/hyperactivity disorder (ADHD) [6][8] - The company has received Orphan Drug Designation from the FDA for brilaroxazine in treating pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) [8]

Reviva Pharmaceuticals -Reviva Announces Publication on Clinical Vocal Biomarker Data from the RECOVER Phase 3 Clinical Trial of Brilaroxazine to Treat Negative Symptoms in Schizophrenia - Reportify