- Minerva Neurosciences (NASDAQ:NERV) shares surge over 35% during post-market trading after the company posted promising results from its open-label extension (OLE) of the late-stage trial of roluperidone for the treatment of negative symptoms (NS) of schizophrenia.
- In the double-blind, placebo-controlled portion of the Phase 3 trial, a total of 515 patients were randomized in a 1:1:1 ratio to 32 mg/day roluperidone, 64 mg/day roluperidone, or placebo for 12 weeks, and 513 patients received study drugs.
- The company argued that the study data supported its view that roluperidone, administered without concomitant treatment with antipsychotics, can potentially improve negative symptoms of schizophrenia and social functioning over the long term.
- Continuous improvement in negative symptoms as measured by Positive and Negative Syndrome Scale (PANSS), Marder Negative Symptom Factor Score (NSFS) were 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 was observed.
- The treatment had a favorable safety profile with few serious adverse events and no evidence of somnolence, extrapyramidal side effects or weight gain.
- 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.