New Data Shows Early and Sustained Benefit of Ingrezza in Huntington Disease Chorea

Valbenazine (Ingrezza^®) has demonstrated consistently greater improvements in adults with chorea associated with Huntington disease (HD) from week 2 to 12 compared with placebo, according to exploratory results from the phase 3 KINECT-HD study. 

Ingrezza is an inhibitor of vesicular monoamine transporter 2 (VMAT2), a transporter that regulates monoamine uptake from the cytoplasm to the synaptic vesicle for storage and release. The randomized, double-blind, placebo-controlled KINECT-HD study (ClinicalTrials.gov Identifier: NCT04102579) evaluated the efficacy and safety of valbenazine in adults with chorea associated with HD.

Patients were randomly assigned to receive valbenazine orally once daily (started at 40 mg/day and increased every 2 weeks in 20 mg increments up to a max of 80 mg/day if needed) or placebo for 12 weeks. The primary endpoint was the change in the Unified Huntington Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) score from baseline to the end of the treatment period (average score at weeks 10 and 12). The TMC score is rated from 0 (no chorea) to 4 for 7 different parts of the body; total scores range from 0 to 28.

According to new exploratory analysis, valbenazine 40 mg achieved greater placebo-adjusted improvement in chorea as early as week 2 and sustained greater efficacy through week 12 compared with placebo. Moreover, a consistently higher proportion of patients rated “much improved” or “very much improved” based on the Clinical Global Impression of Change (CGI-C) and Patient Global Impression of Change (PGI-C) when treated with Ingrezza at all study visits compared with placebo.

These data will be presented at the MDS International Congress of Parkinson’s Disease and Movement Disorders^® August 27-31 in Copenhagen, Denmark. Additionally, the new data supports previously reported data which showed that treatment with valbenazine achieved a statistically significant mean reduction in TMC at the end of the treatment period compared with placebo. 

“The exploratory analysis from our KINECT-HD study further exemplifies the value of Ingrezza as a now approved medication for [Huntington disease] chorea with improvements seen with treatment as early as [2] weeks,” said Eiry W. Roberts, MD, Chief Medical Officer at Neurocrine Biosciences. “Additional analyses presented add to the body of evidence regarding the use of Ingrezza for this patient population, including an increased understanding of UHDRS^® TMC scores that signal clinically meaningful chorea improvements.”

Ingrezza is currently approved for the treatment of tardive dyskinesia and chorea associated with HD. The product is available as 40 mg, 60 mg, and 80 mg capsules.

This article originally appeared on MPR