==Minerva Neurosciences (NERV) to advance schizophrenia drug to late-stage trials

Planned initiation of MIN-101 Phase 3 development in second half of 2017

WALTHAM, Mass., May 15, 2017 (GLOBE NEWSWIRE) -- Following a recent "end-of-Phase 2" meeting with the U.S. Food and Drug Administration (FDA), Minerva Neurosciences, Inc. (NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced its plans to initiate Phase 3 development of MIN-101, a drug targeting negative symptoms in schizophrenia patients.  A pivotal Phase 3 trial with MIN-101 is expected to be initiated in the second half of 2017.

The Phase 3 trial design will be a 12-week, double-blind, randomized, placebo-controlled, monotherapy study testing two doses of MIN-101 in patients with negative symptoms and a diagnosis of schizophrenia.  To be eligible for this study, patients will be required to have stable negative and positive symptoms over several months prior to enrollment, with a specified minimum threshold baseline score on the Positive and Negative Syndrome Scale (PANSS) negative sub-scale. 

After the double-blind phase, patients may enter a 36-week open label extension phase in which all patients will receive active treatment. This multi-center, international trial is expected to enroll approximately 500 patients at approximately 60 clinical sites across the U.S. and Europe.