Minerva Neurosciences, Inc. Announces Completion of Patient Screening in its Ongoing Phase 3 Trial with Roluperidone to Treat Negative Symptoms in Schizophrenia
January 06, 2020 at 04:51 pm EST
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Minerva Neurosciences, Inc. announced the completion of patient screening in its ongoing Phase 3 trial with roluperidone to treat negative symptoms in schizophrenia. A total of 857 patients have been screened, and the enrollment of at least 501 patients is expected to be completed before the end of January 2020. Top-line results from the 12-week, double-blind portion of the trial are expected in the second quarter of 2020. This trial is a multicenter, randomized, double-blind, parallel group, placebo-controlled, 12-week study to evaluate the efficacy and safety of 32 milligram (mg) and 64 mg doses of roluperidone as measured by the Positive and Negative Syndrome Scale Marder negative symptoms factor score, the primary endpoint. Secondary endpoints include the Personal and Social Performance Scale and Clinical Global Impression of Severity. Patients are being randomized 1:1:1 to the 32 mg and 64 mg doses of roluperidone and to placebo. The core 12-week phase of the trial is followed by a 40-week, open-label extension period during which patients on the drug continue receiving their original dose and patients on placebo receive one of the two doses of roluperidone.
Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company, which focused on the development and commercialization of product candidates to treat patients suffering from central nervous system (CNS) diseases. It is engaged in developing roluperidone for the treatment of negative symptoms in patients with schizophrenia and have exclusive rights to develop and commercialize MIN-301 for the treatment of Parkinson's disease. It has also co-developed seltorexant for the treatment of insomnia disorder and adjunctive treatment of the major depressive disorder (MDD). Roluperidone is a compound that blocks serotonin, sigma, and a-adrenergic receptors that are involved in the regulation of mood, cognition, sleep, and anxiety. Roluperidone has been designed to block a specific subtype of serotonin receptor called 5-HT2A. MIN-301 is a soluble recombinant form of the Neuregulin-1b1 (NRG-1b1), protein, for the treatment of Parkinson's disease and for other neurodegenerative disorders.
Minerva Neurosciences, Inc. Announces Completion of Patient Screening in its Ongoing Phase 3 Trial with Roluperidone to Treat Negative Symptoms in Schizophrenia