Ingrezza may reduce chorea severity in Huntington’s disease
Neurocrine Biosciences announced data from a phase 3 trial of Ingrezza that showed it reduced chorea severity among patients with Huntington’s disease.
The trial, called KINECT-HD, examined the efficacy, safety and tolerability of Ingrezza (valbenazine, Neurocrine Biosciences), a selective vesicular monoamine transporter 2 inhibitor.
"The positive results of the KINECT-HD study move us closer to bringing valbenazine as a potential treatment option to patients in the U.S. living with chorea, one of the most common symptoms of Huntington’s disease," Eiry W. Roberts, MD, chief medical officer at Neurocrine Biosciences, said in a press release.
Results of the randomized, double-blind, placebo-controlled study showed an association between valbenazine treatment and a placebo-adjusted mean reduction in the Toxal Maximal Chorea (TMC) score of 3.2 units (P < .0001), which represented a highly statistically significant chorea improvement. The TMC score is a component of the motor assessment of the Unified Huntington's Disease Rating Scale and examines chorea in the face, oral-buccal-lingual region, trunk and each limb independently. The score consists of the sum of the individual scores and ranges between 0 and 28.
Valbenazine treatment also showed statistically significant outcomes on the study’s secondary endpoints, Clinical Global Impression of Change Response Status and Patient Global Impression of Change Response Status. The trial’s treatment-emergent adverse events appeared consistent with the drug’s known safety profile. Researchers reported no suicidal behavior or worsening of suicidal ideation among participants treated with valbenazine.
KINECT-HD study data will be presented at a medical conference next year.
“We will review the complete data and begin preparing a supplemental new drug application for submission to the [FDA] next year,” Roberts continued in the release. “In the meantime, we will continue dosing in the KINECT-HD2 study, which is evaluating the long-term safety and tolerability of valbenazine in this same patient population."