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Neurocrine Biosciences Announces Top-Line Results from Phase II INTERACT Study Evaluating Luvadaxistat (NBI-1065844) for the Treatment of Negative Symptoms and Cognitive Impairment Associated with Schizophrenia (CIAS)
- Negative Outcome on Primary Endpoint Measured by the Change from Baseline on the Positive and Negative Syndrome Scale/Negative Symptom Factor Score (PANSS
About this update from Neurocrine Biosciences, Inc.
[{"type":"text","content":"- Negative Outcome on Primary Endpoint Measured by the Change from Baseline on the Positive and Negative Syndrome Scale/Negative Symptom Factor Score (PANSS NSFS)\n - Positive Outcome on Cognitive Assessment Secondary Endpoints Support Potential Further Clinical Development of Luvadaxistat\n - No New Safety Signals Compared to Previous Trials of Luvadaxistat\n\n\nSAN DIEGO, March 2, 2021 /PRNewswire/ -- Neurocrine Biosciences (Nasdaq: NBIX) today announced that investigational drug luvadaxistat (NBI-1065844/TAK-831) did not meet its primary endpoint in the Phase II INTERACT study in adults with negative symptoms of schizophrenia, as measured by the change from baseline on the PANSS NSFS at Day 84. Luvadaxistat met secondary endpoints of cognitive assessment, which merit further clinical evaluation. The adverse event profiles for luvadaxistat were consistent with previous trials. Takeda Pharmaceutical Company Limited (\"Takeda\") granted an exclusive license to Neurocrine Biosciences for seven pipeline programs, including luvadaxistat, in June 2020. The results from the Phase II INTERACT study are being evaluated to determine next steps for development activities.\n\n \n \n \n \n \n \n\n \n\"The Phase II INTERACT study was a well-designed and executed clinical study that resulted in a negative outcome for luvadaxistat on the primary endpoint assessing the change from baseline in negative symptoms of schizophrenia. We are, however, encouraged that secondary endpoints assessing cognitive performance within the trial were met and that treatment emergent adverse events reported were consistent with previous luvadaxistat studies,\" said Eiry W. Roberts, M.D., Chief Medical Officer of Neurocrine Biosciences. \"The totality of the top-line data from this study therefore support further clinical evaluation of luvadaxistat. We plan to work with our partner Takeda as we move forward.\"\nAbout the INTERACT StudyINTERACT is a Phase II, twelve-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study that evaluated the efficacy, safety, tolerability and pharmacokinetics of three dosing levels of investigational drug luvadaxistat (NBI-1065844/TAK-831) as an adjunctive treatment of adult patients with negative symptoms of schizophrenia. Study enrollment began in January 2018 and included a total of 256 randomized pa...