Positive topline data were announced from a phase 3 study evaluating the efficacy and safety of valbenazine, a selective vesicular monoamine transporter 2 inhibitor, for the treatment of chorea associated with Huntington disease.
The randomized, double-blind, placebo-controlled KINECT-HD study (ClinicalTrials.gov Identifier: NCT04102579) included 128 adults 18 to 75 years of age diagnosed with chorea associated with Huntington disease. Patients were randomly assigned to receive valbenazine orally once daily 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 average score at weeks 10 and 12.
Results showed that valbenazine met the primary endpoint demonstrating a statistically significant placebo-adjusted mean reduction in TMC score of 3.2 units (P <.0001). Treatment with valbenazine was also associated with statistically significant improvements in both Clinical Global Impression of Change response status and Patient Global Impression of Change response status at week 12. The safety profile of valbenazine was consistent with its known profile.
“The positive results of the KINECT-HD study move us closer to bringing valbenazine as a potential treatment option to patients in the US living with chorea, one of the most common symptoms of Huntington disease,” said Eiry W. Roberts, MD, Chief Medical Officer at Neurocrine Biosciences. “We will review the complete data and begin preparing a supplemental New Drug Application (sNDA) for submission to the US Food and Drug Administration next year.”
The long-term safety and tolerability of valbenazine is currently being investigated in the open-label KINECT-HD2 study (ClinicalTrial Identifier: NCT04400331).
Valbenazine is marketed under the brand name Ingrezza and is approved for the treatment of adults with tardive dyskinesia.
Neurocrine Biosciences announces positive phase 3 data for KINECT-HD study evaluating valbenazine for chorea associated with Huntington disease. News release. Neurocrine Biosciences, Inc. Accessed December 8, 2021. https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-positive-phase-3-data-for-kinect-hd-study-evaluating-valbenazine-for-chorea-associated-with-huntington-disease-301439605.html.