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Neurocrine Biosciences Announces Publication of Full KINECT™-HD Phase 3 Study Results of Valbenazine for the Treatment of Chorea Associated with Huntington's Disease in The Lancet Neurology
- Statistically Significant Improvement in Chorea Associated with Huntington's Disease Seen as Early as Week 2 - Chorea Improvement Supported by Statistically
About this update from Neurocrine Biosciences, Inc.
[{"type":"text","content":"- Statistically Significant Improvement in Chorea Associated with Huntington's Disease Seen as Early as Week 2\n- Chorea Improvement Supported by Statistically Significant Clinical Global Impression of Change (CGI-C) Response Status and Patient Global Impression of Change (PGI-C) Response Status Scores at Week 12\n- First Phase 3 Study to Implement Huntington's Disease Health Index (HD-HI), a Patient-Reported Outcome Measure, Showed Reduced Disease Burden as Reported by Patients Receiving Valbenazine versus Placebo\n- Supplemental New Drug Application (sNDA) Filed, with Prescription Drug User Fee Act (PDUFA) Target Date Set for August 20, 2023\nSAN DIEGO, May 19, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced that the complete study results from its Phase 3 KINECT™-HD study investigating valbenazine for the treatment of chorea associated with Huntington's disease (HD) has been published in The Lancet Neurology online edition and will appear in the June 2023 print issue. The study met pre-defined primary and secondary endpoints of improvement in chorea severity and global impression of change, demonstrating a reduction in chorea symptoms associated with HD and improvement of overall chorea severity as noticed by clinicians and patients, with improvement seen as early as Week 2 of the initial dose in the 12-week study.\n\"We're pleased to share the KINECT-HD full study results with the scientific community and its acceptance in an esteemed journal following rigorous peer-review,\" said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. \"There remains a need for symptomatic treatments for chorea associated with Huntington's disease, and this manuscript provides an in-depth overview of the KINECT-HD study data and the potential of valbenazine to fulfill this need.\"\nValbenazine is a novel vesicular monoamine transporter 2 (VMAT2) inhibitor. VMAT2 inhibitors have been shown to reduce chorea associated with HD.\n\"More than 90 percent of adults with HD experience chorea,\" said Erin Furr Stimming, M.D., the paper's lead author and professor in the Department of Neurology and Memorial Hermann Chair with McGovern Medical School at UTHealth Houston. \"The KINECT-HD study data demonstrated statistically significant improvement in chorea associated with HD as compared with placebo. ...