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Minerva Neurosciences Announces Publication of Roluperidone Phase 3 Study Results in Schizophrenia Bulletin
Trial Results Confirm the Potential of Roluperidone To Treat Negative Symptoms and Improve Everyday Functioning in Patients with SchizophreniaWALTHAM, Mass.,
About this update from Minerva Neurosciences, Inc
[{"type":"text","content":"Trial Results Confirm the Potential of Roluperidone To Treat Negative Symptoms and Improve Everyday Functioning in Patients with SchizophreniaWALTHAM, Mass., Feb. 28, 2022 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that results from the Phase 3 clinical trial of roluperidone to treat negative symptoms in patients with schizophrenia have been published in Schizophrenia Bulletin. The study authors conclude that this study confirms the potential of roluperidone to treat the negative symptoms in individuals with schizophrenia as well as improve everyday functioning. The publication, entitled, “Efficacy and Safety of Roluperidone for the treatment of negative symptoms of schizophrenia,” reports on the Phase 3 placebo-controlled multi-national trial of roluperidone, a compound with antagonist properties for 5-HT2A, sigma2 and α1A-adrenergic receptors, targeting negative symptoms in patients with schizophrenia. The goal of the trial was to confirm the findings of a previous Phase 2 trial with a similar patient population and methodology that had demonstrated roluperidone superiority over placebo. The Company previously disclosed results of the Phase 3 trial of roluperidone in May 2020 and open-label results in May 2021. The Phase 3 study included 513 patients with schizophrenia with moderate to severe negative symptoms. Study patients were administered either 32 mg/day of roluperidone, 64 mg/day of roluperidone, or placebo for 12 weeks. The primary endpoint was the PANSS-derived Negative Symptom Factor Score (NSFS) and the key secondary endpoint was Personal and Social Performance scale (PSP) total score. The study found that NSFS scores improved (were lower) for patients receiving roluperidone 64 mg compared to placebo. The intent-to-treat (ITT) analysis data set (p ≤0.064) marginally missed statistical significance, but reached nominal significance (p ≤0.044) for the modified-ITT (m-ITT) data set. Changes in PSP total score were statistically significantly better on roluperidone 64 mg compared to placebo for both ITT and m-ITT (p ≤0.021 and p ≤0.017, respectively). About roluperidone On November 3, 2021, Minerva Neurosciences announced that the U. S. Food and Drug Adm...