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Minerva Neurosciences Announces the Results of the Phase 3 Trial of Roluperidone for the Treatment of Negative Symptoms of Schizophrenia Following the Completion of the 40-Week Open-Label Extension
Key results Continuous improvement in negative symptoms as measured by Positive and Negative Syndrome Scale (PANSS) Marder Negative Symptom Factor Score
About this update from Minerva Neurosciences, Inc
[{"type":"text","content":"Key results Continuous improvement in negative symptoms as measured by Positive and Negative Syndrome Scale (PANSS) Marder Negative Symptom Factor Score (NSFS) observed over one year (12-week double-blind and 40-week open-label periods) in patients receiving both 64 mg and 32 mg doses Continuous improvement in Personal and Social Performance (PSP) total score over one year, suggesting improvement in patients’ everyday life functioningFavorable safety profile with few serious adverse events and no evidence of somnolence, extrapyramidal side effects or weight gainLimited number of relapses observed over one year Results provide additional support for continued development of roluperidone and submission of NDA following completion of bioequivalence study and other work to address FDA comments from the Company’s Type C meeting held on November 10, 2020Findings to be discussed during Q1 2021 conference call and webcast on May 12, 2021, at 8:30 a.m. WALTHAM, Mass., May 11, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today announced results from the 40-week open-label extension (OLE) of its phase 3 trial of roluperidone for the treatment of negative symptoms (NS) of schizophrenia. The OLE followed the 12-week double-blind, placebo-controlled portion of this trial. During the OLE, both investigators and patients were blinded to the roluperidone dose received (see “About the trial” below). Over the 40-week OLE period, 333 patients participated, of whom 166 patients received the 32 mg dose and 167 patients received the 64 mg dose. The mean improvement in negative symptoms was 6.8 points in the 32 mg arm and 7.5 points in the 64 mg arm. PSP total score improved by a mean of 12.3 points in the 32 mg arm and 14.5 points in the 64 mg arm, suggesting functional improvement. The mean improvement in positive symptoms, as measured by the PANSS positive symptom subscore, was 1.9 points in the 32 mg arm and 1.8 points in the 64 mg arm. Reduced emotional experience, as measured by a sub-factor of the NSFS that assesses a patient's motivation to take part in everyday life activities, had a mean improvement of 2.8 points in the 32 mg group and 3.0 points in the 64 mg group. The relapse rate during the O...