Ingrezza (valbenazine) capsules interim data demonstrating sustained improvements in chorea associated with Huntington's disease presented at Huntington Study Group 2023

Interim data suggest one-capsule, once-daily Ingrezza improved chorea at the first evaluation at Week 2 with sustained efficacy through Week 50. These data were presented at the 30th Annual Meeting of the Huntington Study Group on November 2–4 in Phoenix. "These interim data provide insight on the clinically meaningful and sustained improvements participants are experiencing with for the treatment of chorea," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences "We look forward to analyzing additional data as they become available."

KINECT-HD2 includes adults with genetically confirmed motor-manifest HD (n=127), most of whom (n=98) completed KINECT-HD, a Phase III, randomized, double-blind, placebo-controlled study. Both studies were conducted in collaboration with the Huntington Study Group (HSG) and contributed to the recent FDA approval of Ingrezza for chorea associated with HD. Concomitant antipsychotic use is also being explored in the open-label study.

The current interim results from KINECT-HD2 (Sustained Improvements With Once-Daily Valbenazine in Chorea Associated With Huntington's Disease: Interim Results From a Long-Term Open-Label Study, Poster # 64) suggest that Ingrezza improved chorea at the first evaluation (Week 2) when participants were taking the lowest dose of 40 mg, with efficacy sustained through Week 50 at less than 80 mg

More than half of participants (60.9 percent) and investigators (58.9 percent) rated symptoms as "much improved" or "very much improved" at Week 6, and about three-quarters of participants (74.2 percent) and investigators (76.9 percent) rated symptoms as "much improved" or "very much improved" by Week 50. The most common treatment-emergent adverse events at the time of the analysis were consistent with those observed in KINECT-HD, including falls (30.4 percent), fatigue (24.0 percent) and somnolence (24.0 percent).

Neurocrine Biosciences will also present new data from KINECT-HD (A Wearable Movement Sensor Substudy of KINECT-HD, a Phase III Trial of Valbenazine for the Treatment of Chorea Associated With Huntington's Disease, Poster #65), which was the first Phase III clinical trial to include a wearable movement sensor substudy. Significant improvements in truncal chorea and gait asymmetry measures were seen from baseline to maintenance following the Week 10 visit in the Ingrezza-treated group (P < 0.05) compared to placebo. These findings support how digital measurements can be used to detect meaningful symptom changes in individuals with HD to improve clinical research and care.