Efficacy of Brilaroxazine - Brilaroxazine demonstrated a significant decrease of 18 points in PANSS total score at Week 52 compared to baseline (p ≤ 0.0001) [41] - There was a 5-point decrease in PANSS positive symptoms score at 12 months with brilaroxazine pooled (15, 30 & 50 mg) vs baseline (p ≤ 0.001) [47] - Brilaroxazine showed a 4.4-point decrease in PANSS negative symptoms score at 12 months compared to baseline (p ≤ 0.001) [50] - 58.5% of patients showed >1-point improvement on the CGI-S scale at 12 months with brilaroxazine pooled (15, 30, & 50 mg) vs baseline (p ≤ 0.001) [69] Safety and Tolerability of Brilaroxazine - In the 52-week open-label trial, 37.2% of patients experienced any treatment emergent adverse event (TEAE) [84] - The pooled brilaroxazine dose group reported a mild weight gain of 1.52 kg [104] - There was a decrease in cholesterol of -8.3 mg/dL overall (p=0.030) and LDL cholesterol of -8.0 mg/dL overall (p=0.0093) in the 12-month OLE trial [90] - A clinically significant decrease in serum prolactin levels of -12.50 ug/L overall was observed from baseline to week-52/EOT [94] - There was an improvement in thyroid (T3) hormone levels of 0.044 ug/L overall (P ≤ 0.05) [97] Trial Design and Demographics - The RECOVER open-label extension (OLE) trial enrolled 446 patients with stable schizophrenia [37]

Core Insights - Reviva Pharmaceuticals announced positive results from the Phase 3 RECOVER open-label extension study of brilaroxazine for schizophrenia, demonstrating sustained efficacy and a well-tolerated safety profile over one year [1][2][5] Efficacy and Safety - Brilaroxazine showed robust broad-spectrum efficacy across all major symptom domains of schizophrenia, with a statistically significant reduction in PANSS total score of -18.1 at 12 months [3][4] - The treatment was generally well-tolerated, with a discontinuation rate of 35%, primarily due to withdrawal of consent and loss to follow-up [1][9] - Improvements in multiple neuroinflammatory markers were observed, suggesting enhanced efficacy and reduced side effects [1][2][9] Clinical Data - The study included a pooled analysis of 446 patients receiving doses of 15 mg, 30 mg, and 50 mg, showing dose-dependent efficacy [2][4] - Key findings included a reduction in negative symptoms by -4.4 at 12 months and significant improvements in personal and social performance scores [3][4] - The treatment also demonstrated a low incidence of treatment-emergent adverse events, with most being mild or moderate in severity [9][10] Future Development - Reviva aims to advance brilaroxazine towards regulatory submission, with plans to explore its use in other neuropsychiatric conditions such as bipolar disorder and major depressive disorder [10][11] - The company has received Orphan Drug Designation from the FDA for brilaroxazine in treating pulmonary arterial hypertension and idiopathic pulmonary fibrosis [11][12]