(#58) Valbenazine Improves the Impacts and Symptoms of Tardive Dyskinesia: Topline Results from the Phase 4 KINECT-PRO Study

Abstract: Once-daily valbenazine is approved for tardive dyskinesia (TD) and Huntingtonís chorea. KINECT-PRO is the first study to report the effects of an approved TD medication on the impacts of TD using multiple validated patient-reported outcomes (PROs). It included: screening (4 wks); treatment with valbenazine 40 mg (4 wks); continuation at 40 mg or increase to 60 or 80 mg (12 wks); stable dosing with 40, 60, or 80 mg (8 wks); and follow-up (2 wks). Participants had mild-to-severe TD and mild-to-severe associated distress (per Abnormal Involuntary Movement Scale [AIMS] items 8 and 10). PROs included the Tardive Dyskinesia Impact Scale (TDIS), Sheehan Disability Scale (SDS), and EuroQoL Groupís EQ Visual Analog Scale (EQ-VAS). Mean changes from baseline (CFB) for PROs and AIMS total score (summed items 1-7) were analyzed by TD severity (mild, moderate/severe), psychiatric diagnosis (schizophrenia/schizoaffective disorder [SCHZ], major depressive/bipolar disorder [MOOD]), and overall. Of 59 enrolled participants (24 mild, 35 moderate/severe; 27 SCHZ, 32 MOOD), 45 were included for efficacy analyses. Overall, PRO and AIMS improvements were observed by Wk4. CFB at Wk24 overall and by TD severity (mild, moderate/severe) were: TDIS (-8.0, -6.8, -8.9); SDS social life (-2.3, -1.8, -2.8) and family life (-1.6, -1.3, -1.8); EQ-VAS (+13.1, +12.8, +13.3); AIMS (-6.8, -5.6, -7.8). In SCHZ and MOOD subgroups, CFB were: TDIS (-5.8, -9.7); SDS social life (-1.6, -2.9) and family life (-0.7, -2.3); EQ-VAS (+8.3, +17.0); AIMS (-5.8, -7.6). These results demonstrate clinically meaningful and sustained improvements with valbenazine on TD severity and patient impact.Short Description: Valbenazine, a uniquely selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is approved for the treatment of adults with tardive dyskinesia (TD) and chorea associated with Huntingtonís disease. The open-label KINECT-PRO trial is the first to study and report the effects of a VMAT2 inhibitor on the impacts of TD as assessed using multiple validated patient-reported outcomes. The results of this study demonstrate clinically meaningful and sustained improvements with valbenazine on TD severity and patient impact.Name of Sponsoring Organization(s): Neurocrine Biosciences, Inc.