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- Minerva Neurosciences Inc NERV has announced results from the 40-week open-label extension (OLE) of its Phase 3 trial evaluating roluperidone for the treatment of negative symptoms (NS) of schizophrenia.
- Over the 40-week OLE period, 333 patients participated. 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.
- Personal and Social Performance (PSP) score improved by a mean of 12.3 points in the 32 mg arm and 14.5 points in the 64 mg arm.
- The mean improvement in positive symptoms was 1.9 points in the 32 mg arm and 1.8 points in the 64 mg arm.
- Reduced emotional experience 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 was 15/166 patients (9%) in the 32 mg arm and 10/167 (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 were generally mild to moderate in severity.
- Minerva will discuss these results during its Q1 2021 conference call and webcast today at 8:30 a.m. ET.
- Price Action: NERV shares are trading 29.1% higher at $2.88 during the premarket session on the last check Wednesday.
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NERVMinerva Neurosciences Inc
$1.78-%
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