Data readout expected in the second quarter of 2020
WALTHAM, Mass., Feb. 05, 2020 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies addressing high unmet medical needs in the treatment of central nervous system (CNS) disorders, today announced the completion of patient randomization in the pivotal, Phase 3 multicenter trial of roluperidone, its lead product, for the treatment of negative symptoms in schizophrenia.
A total of 515 patients have been randomized in this trial, compared to the original goal of 501 patients. The trial, which is being conducted at clinical sites in the U.S. and Europe, is a 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 Marder negative symptoms factor score of the Positive and Negative Syndrome Scale, 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 placebo. The core 12-week double-blind 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. Top-line results from the 12-week, double-blind portion of the trial are expected in the second quarter of 2020.
"The completion of patient enrollment marks a major milestone in the Phase 3 trial with roluperidone," said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. "We believe the data from this trial have the potential to lead to a significant new treatment option for schizophrenia, as no pharmacological agent is approved to treat negative symptoms, which is the single greatest unmet need for patients with this disease, their families and their physicians."
About Minerva Neurosciences
Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of product candidates to treat CNS diseases. Minerva's proprietary compounds include: roluperidone.
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management's expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the timing and scope of future clinical trials and results of clinical trials with roluperidone. The forward-looking statements in this press release are based on information available to us as of the date hereof, and we disclaim any obligation to update any forward-looking statements, except as required by law.
Contact:
William B. Boni
VP, Investor Relations
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376
