- 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 functioning
- Favorable safety profile with few serious adverse events and no evidence of somnolence, extrapyramidal side effects or weight gain
- Limited 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, 2020
- Findings 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The relapse rate during the OLE, defined as patients being withdrawn from the trial due to worsening of symptoms of psychosis, was 15 patients out of 166 patients (9%) in the 32 mg arm and 10 patients out of 167 patients (6%) in the 64 mg arm. Over the one-year duration the relapse rate was 11.7% overall.
Roluperidone at both doses was safe and well tolerated, and treatment-emergent adverse events (TEAE) were generally mild to moderate in severity. The most frequently reported TEAE in the overall group of 333 patients that participated in the OLE were headaches in 26 patients (7.8%), followed by worsening of schizophrenia in 18 patients (5.4%) and insomnia in 15 patients (4.5%). No other TEAE was reported by more than 4% of the patients. There was one death (45 year old male) in the 64 mg arm due to treatment-unrelated respiratory failure that occurred after treatment discontinuation. Twenty patients (6%) experienced serious adverse events, with the majority of them associated with the disease characteristics, and only 5 were judged by the investigator to be related to roluperidone. In total, 37 patients (11%) did not complete the OLE due to TEAE, with 25 patients (7.5%) due to relapse-related events and the remaining 12 patients due to a variety of other TEAE reported in ≤1% of the patients. Few QT prolongations were observed during the OLE and were generally transient in duration, and only one in the 64 mg arm led to discontinuation from the study.
"I am delighted to announce that our one-year Phase 3 trial, now completed, supports our view that roluperidone, administered without concomitant treatment with antipsychotics, can potentially improve negative symptoms of schizophrenia and social functioning over the long term," said Dr. Luthringer. "We believe the data also suggest that roluperidone's unique pharmacology and mechanism of action potentially help to maintain the stability of psychotic symptoms over the duration of treatment.
"The encouraging new data reported today supplement our clinical database describing the effect of roluperidone for the treatment of negative symptoms of schizophrenia, which represent a significant unmet medical need for which there is currently no approved treatment in the U.S.," said Dr. Luthringer.