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     364  0 Kommentare Minerva Neurosciences Announces Outcome of Type C Meeting with FDA and Next Steps in the Development of Roluperidone - Seite 3

    Roluperidone Phase 3: ITT and mITT NSFS & PSP total score change from baseline scores and p-values
    Timepoint
    Intent-to-Treat Modified Intent-to-Treat
    (Excluding patients from 1 site)
    Placebo
    (N=172)
    64 mg Roluperidone
    (N=171)
    p-value Placebo
    (N=167)
    64 mg Roluperidone
    (N=162)
    p-value
    Primary Endpoint: Marder Negative Symptoms Factor Score
    Week 2 -1.6 (0.22) -1.9 (0.22) NS -1.6 (0.22) -1.9 (0.22) 0.311
    Week 4 -2.0 (0.26) -2.9 (0.26) 0.007 -2.0 (0.26) -3.0 (0.27) 0.005
    Week 8 -2.9 (0.30) -3.8 (0.32) 0.027 -2.9 (0.31) -3.9 (0.32) 0.021
    Week 12 -3.5 (0.34) -4.3 (0.38) 0.064 -3.5 (0.35) -4.5 (0.35) 0.044
    Key Secondary Endpoint: Personal and Social Performance Total Score
    Week 4 1.3 (0.56) 3.2 (0.56) 0.005 1.2 (0.58) 3.3 (0.59) 0.004
    Week 8 2.8 (0.66) 4.8 (0.66) 0.019 2.8 (0.68) 4.9 (0.68) 0.014
    Week 12 3.9 (0.73) 6.1 (0.73) 0.021 3.8 (0.75) 6.2 (0.77) 0.017

    About Minerva Neurosciences:

    Minerva’s portfolio of compounds includes: roluperidone (MIN-101), in clinical development for schizophrenia; a potential royalty stream from seltorexant (MIN-202 or JNJ-42847922), in clinical development for insomnia and MDD; and MIN-301, in pre-clinical development for Parkinson’s disease. Minerva’s common stock is listed on the NASDAQ Global Market under the symbol “NERV.” For more information, please visit www.minervaneurosciences.com.

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    Minerva Neurosciences Announces Outcome of Type C Meeting with FDA and Next Steps in the Development of Roluperidone - Seite 3 WALTHAM, Mass., Dec. 01, 2020 (GLOBE NEWSWIRE) - Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that …

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