New three-year data demonstrates sustained clinical benefits and established safety profile of Ingrezza (valbenazine) capsules for Huntington’s disease chorea – Neurocrine Biosciences

Neurocrine Biosciences, Inc. presented new data from the open-label KINECT-HD2 study demonstrating an established long-term safety profile, tolerability and sustained improvements in chorea severity through three years of treatment with once-daily Ingrezza (valbenazine) capsules in adults with Huntington’s disease. These findings were presented at the 2025 MDS International Congress of Parkinson’s Disease and Movement Disorders in Honolulu.

“Most people with Huntington’s disease experience chorea, one of the most debilitating symptoms of the condition that can interfere with motor coordination, gait, swallowing and speech,” said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. “The KINECT-HD2 study findings demonstrated that Ingrezza provided sustained and meaningful chorea management with improvements observed early and maintained over three years of treatment. Additionally, data showed that concomitant antipsychotic use had no effect on chorea improvement.”

The KINECT-HD2 study included 154 adult participants who received once-daily Ingrezza for up to three years, with an ongoing optional extended-maintenance period. Safety and tolerability were assessed through treatment-emergent adverse events (TEAEs), including serious TEAEs and discontinuations from treatment or the study due to a TEAE. Efficacy was evaluated through Week 156 using changes from baseline in the Unified Huntington’s Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) score and response status (“much improved” or better) on the Clinical Global Impression of Change (CGI-C) and Patient Global Impression of Change (PGI-C) scores. Efficacy was also evaluated through Week 50 using TMC mean changes from baseline in subgroups categorized by concomitant antipsychotic use.

Results from this analysis indicated that long-term INGREZZA treatment (at doses of 40 mg, 60 mg or 80 mg) provided early and sustained improvements in chorea severity, and concomitant use of antipsychotic medication had no apparent effect on chorea improvement:

i) Robust improvements in the mean (±standard error of the mean [SEM]) UHDRS TMC score were observed by Week 2 (-3.4±0.3 [n=146]) at the lowest dose of Ingrezza (40 mg).

ii) Mean TMC improvements from baseline were observed at all post-baseline study visits (from Week 2 to Week 156).

iii) PGI-C response status at Week 2 with Ingrezza was 34.5% (50/145) followed by 75.9% at Week 104 and 77.8% at Week 156. Similar results were found for CGI-C.

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:

i) 150/154 (97.4%) of participants reported at least one TEAE.

• a) The most common TEAEs were falls (42.9%), somnolence (25.3%) and fatigue (21.4%).
• b) Individual TEAEs were judged as serious in <2% of participants.
• c) Discontinuations due to TEAEs occurred in 15.6% of participants.

About KINECT-HD2
KINECT-HD2 is an ongoing open-label study to evaluate the long-term safety and tolerability, as well as the maintenance of effects, of Ingrezza in patients with chorea associated with Huntington’s disease (HD). The maintenance period up to Week 156 of treatment enrolled 154 adults 18 to 75 years of age who have been diagnosed with motor-manifest HD and who have sufficient chorea symptoms to meet study protocol criteria. Concomitant antipsychotic use is allowed in the study.