Neurocrine Biosciences Announces Publication of Full KINECT™-HD Phase 3 Study Results of Valbenazine
Rochester, NY, May 19, 2023 --(PR.com)-- 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 Significant Clinical Global Impression of Change (CGI-C) Response Status and Patient Global Impression of Change (PGI-C) Response Status Scores at Week 12.
- 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.
- Supplemental New Drug Application (sNDA) Filed, with Prescription Drug User Fee Act (PDUFA) Target Date Set for August 20, 2023.
Neurocrine Biosciences, Inc. 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 its primary and secondary endpoints, 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.
The KINECT-HD randomized double-blind, placebo-controlled Phase 3 study was conducted with 128 participants at 46 Huntington Study Group (HSG)–credentialed sites in North America.
The primary endpoint was a reduction in severity of chorea, the cardinal motor feature in HD, as measured by change in the HSG-developed Unified Huntington’s Disease Rating Scale (UHDRS®) Total Maximal Chorea (TMC) score from baseline to the average score at weeks 10 and 12. The TMC score is part of the motor assessment of the UHDRS that measures chorea.
- Statistically Significant Improvement in Chorea Associated with Huntington’s Disease Seen as Early as Week 2.
- 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.
- 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.
- Supplemental New Drug Application (sNDA) Filed, with Prescription Drug User Fee Act (PDUFA) Target Date Set for August 20, 2023.
Neurocrine Biosciences, Inc. 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 its primary and secondary endpoints, 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.
The KINECT-HD randomized double-blind, placebo-controlled Phase 3 study was conducted with 128 participants at 46 Huntington Study Group (HSG)–credentialed sites in North America.
The primary endpoint was a reduction in severity of chorea, the cardinal motor feature in HD, as measured by change in the HSG-developed Unified Huntington’s Disease Rating Scale (UHDRS®) Total Maximal Chorea (TMC) score from baseline to the average score at weeks 10 and 12. The TMC score is part of the motor assessment of the UHDRS that measures chorea.
Contact
Huntington Study Group
Kristin Keyes
800-487-7671
https://huntingtonstudygroup.org
Kristin Keyes
800-487-7671
https://huntingtonstudygroup.org
Contact
Categories