INGREZZA was generally well tolerated over the long term, and TEAEs observed in the study were consistent with its established safety profile and with known symptoms of Huntington's disease:Â Additional presentations at the 2025 MDS International Congress of Parkinson's Disease and Movement Disorders include: , /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today presented new data from the open-label KINECT-HD2 study demonstrating an established long-term safety profile, tolerability and susta ...

Core Insights - Neurocrine Biosciences announced significant reductions in cognitive and motor-related burdens in adults with Huntington's disease chorea treated with INGREZZA (valbenazine) capsules, based on new patient-reported post-hoc data from the KINECT-HD study [1][4] Group 1: Study Findings - The KINECT-HD study is the first clinical trial to show measurable changes in cognitive and motor disease burden with a vesicular monoamine transporter 2 inhibitor in Huntington's disease patients [1][2] - In the 12-week Phase 3 KINECT-HD clinical trial, INGREZZA showed a significant reduction in chorea severity, with a placebo-adjusted mean reduction in the Total Maximal Chorea (TMC) score of 3.2 units (p<0.0001) [11] - Patient-reported analyses indicated greater reductions in cognitive and motor-related disease burden for INGREZZA compared to placebo across various domains, including memory loss and mobility limitations [3][4] Group 2: Cognitive and Motor-Related Improvements - Statistically significant improvements were observed in cognition-related items, such as memory loss (-0.9 for INGREZZA vs -0.2 for placebo) and decision-making abilities (-1.0 for INGREZZA vs -0.3 for placebo) [3] - For motor-related items, INGREZZA demonstrated larger reductions in scores compared to placebo, including abnormal movements (-1.5 for INGREZZA vs -0.8 for placebo) and impaired coordination (-1.0 for INGREZZA vs -0.4 for placebo) [3][5] Group 3: Background on Huntington's Disease - Huntington's disease is a hereditary progressive neurodegenerative disorder affecting approximately 41,000 adults in the U.S., characterized by motor, cognitive, and psychiatric symptoms [7] - Chorea, a common symptom of Huntington's disease, involves irregular and unpredictable movements that can interfere with motor coordination and daily activities [7] Group 4: About INGREZZA - INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved for treating chorea associated with Huntington's disease and tardive dyskinesia [14][15] - The drug is designed for once-daily administration without the need for titration, making it convenient for patients [16]

Core Insights - Neurocrine Biosciences announced new data from the Phase 4 KINECT-PRO study showing significant improvements in physical, social, and emotional functioning in patients with tardive dyskinesia treated with INGREZZA [1][6][4] Group 1: Study Overview - KINECT-PRO is the first study to evaluate patient-reported outcomes with INGREZZA using multiple validated scales, including the Tardive Dyskinesia Impact Scale [1][6] - The study enrolled 59 patients who received once-daily INGREZZA (40 mg, 60 mg, or 80 mg) for up to 24 weeks, with 52 patients completing the Week 24 visit [2][4] Group 2: Study Objectives and Measures - The primary objective was to assess changes in patient-reported physical and socio-emotional impacts of tardive dyskinesia during treatment [3] - Outcomes were measured at Weeks 4, 8, 16, and 24 using the Tardive Dyskinesia Impact Scale, Sheehan Disability Scale, and EQ Visual Analogue Scale [3] Group 3: Results and Improvements - Improvements in TDIS, SDS, EQ-VAS, and AIMS were observed as early as Week 4 and sustained through Week 24, indicating robust and clinically meaningful enhancements in functioning [4][6] - The mean change from baseline at Week 24 for the overall population showed a reduction of -8.0 in TDIS, -2.3 in social life, -1.6 in family life, an increase of +13.1 in EQ-VAS, and a reduction of -6.8 in AIMS total score [5] Group 4: Subgroup Analysis - Both mild and moderate/severe tardive dyskinesia subgroups showed significant improvements, with mild TD subgroup reporting a mean change of -6.8 in TDIS and +12.8 in EQ-VAS [5][7] - The moderate/severe TD subgroup reported a mean change of -8.9 in TDIS and +13.3 in EQ-VAS [7] Group 5: Safety and Tolerability - The safety and tolerability profile of INGREZZA was consistent with known data, with no new safety concerns identified during the study [7][6]

Company Overview - Neurocrine Biosciences, Inc. is a neuroscience-focused biopharmaceutical company dedicated to developing treatments for neurological, neuroendocrine, and neuropsychiatric disorders [21] - The company has a diverse portfolio that includes FDA-approved treatments for tardive dyskinesia (TD) and other conditions, along with a robust pipeline of compounds in clinical development [21] Campaign Launch - The company launched the "ConnectING with Carnie™" multimedia awareness campaign in partnership with Carnie Wilson to raise awareness about tardive dyskinesia [1][5] - The campaign aims to combat stigma, promote diagnosis, and empower patients to seek treatment options, including INGREZZA® (valbenazine) capsules [5] Tardive Dyskinesia (TD) Awareness - Tardive dyskinesia is characterized by uncontrolled, abnormal movements and is associated with the use of certain antipsychotic medications [6][7] - It is estimated that at least 800,000 adults in the U.S. are affected by TD [7] INGREZZA® (valbenazine) Capsules - INGREZZA is an FDA-approved treatment for adults with tardive dyskinesia and is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor [8][9] - The medication is available in 40 mg, 60 mg, and 80 mg capsules and can be taken once daily without the need for titration [10] Campaign Goals - The ultimate goal of the "ConnectING with Carnie" campaign is to encourage individuals living with TD to seek the help they deserve and to reduce stigma surrounding the condition [2][4] - The campaign will feature personal stories and resources for those affected by TD, aiming to foster open discussions about symptoms and treatment options [3][4]