- 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
The KINECT-HD randomized double-blind, placebo-controlled Phase 3 study was conducted with 128 participants at 46
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.
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