Neurocrine Biosciences Announces Positive Phase 3 Data
December 07, 2021 at 04:35 pm EST
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Neurocrine Biosciences announced positive top-line data from its Phase 3 KINECT-HD study evaluating the efficacy, safety and tolerability of valbenazine, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor being investigated as a once-daily treatment in adults with chorea associated with Huntington disease (HD). The study met the primary endpoint of reduction in severity of chorea, the cardinal motor feature in Huntington disease, as measured by change in the Unified Huntington's Disease Rating Scale (UHDRS®) Total Maximal Chorea (TMC) score from baseline to the average score at weeks 10 and 12. In the randomized, double-blind, placebo-controlled KINECT-HD study, treatment with valbenazine resulted in a placebo-adjusted mean reduction in the TMC score of 3.2 units (p < 0.0001), indicating a highly statistically significant improvement in chorea. The TMC score is part of the motor assessment of the UHDRS® and measures chorea in seven different body parts, including the face, oral-buccal-lingual region, trunk and each limb independently. The TMC score is the sum of the individual scores and ranges from 0 to 28. The secondary endpoints of Clinical Global Impression of Change (CGI-C) Response Status and Patient Global Impression of Change (PGI-C) Response Status were also statistically significant in favor of valbenazine treatment. The treatment emergent adverse events observed in this trial were consistent with the known safety profile of valbenazine. No suicidal behavior or worsening of suicidal ideation was observed in the valbenazine-treated subjects in this study. Data from the Phase 3 KINECT-HD study will be presented at a medical conference in 2022.
Neurocrine Biosciences, Inc. is a neuroscience-focused, biopharmaceutical company. The Company is engaged in discovering and developing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. Its diverse portfolio includes the United States Food and Drug Administration-approved treatments for tardive dyskinesia, chorea associated with Huntingtonâs disease, endometriosis and uterine fibroids, as well as a robust pipeline, including multiple compounds in mid-to late-phase clinical development across its core therapeutic areas. Its commercial products include INGREZZA, ALKINDI, EFMODY, Orilissa and Oriahnn. INGREZZA is marketed as DYSVAL (valbenazine) in Japan and REMLEAS (valbenazine) in other select Asian markets, where Mitsubishi Tanabe Pharma Corporation retains commercialization rights. ALKINDI is marketed as ALKINDI SPRINKLE (hydrocortisone) in the United States, where Eton Pharmaceuticals, Inc. retains commercialization rights.
NEUROCRINE BIOSCIENCES, INC. 
