Minerva Neurosciences Announces First Patient Screened in Global Phase 3 Confirmatory Trial of Roluperidone for the Treatment of Negative Symptoms of Schizophrenia

Core Insights - Roluperidone is the only late-stage drug candidate for treating negative symptoms of schizophrenia, with consistent positive results from prior pivotal trials [1][4] - The first patient has been screened for a global Phase 3 clinical trial evaluating roluperidone as monotherapy for negative symptoms of schizophrenia, which currently has no FDA-approved treatments [2][4] Phase 3 Trial Overview - The Phase 3 trial will enroll approximately 380 patients across 40 clinical sites worldwide, including the US and Europe, following discussions with the FDA on trial design [3][5] - The trial aims to confirm the efficacy of roluperidone on primary negative symptoms at 12 weeks compared to placebo and evaluate long-term relapse of positive symptoms over an additional 40 weeks [5][8] Trial Design and Objectives - The trial consists of two phases: Phase A (12 weeks) focuses on the primary endpoint of change in the Marder Negative Symptoms Factor Score, while Phase B (40 weeks) compares relapse rates with commonly prescribed antipsychotic medications [6][7][8] - The design includes standardized assessments and caregiver engagement to minimize variability and maximize sensitivity to treatment effects [6] Expected Outcomes - Topline data from the 12-week Phase A portion is anticipated in the second half of 2027, which will provide insights into the primary efficacy endpoint [6][7]