Valbenazine improved chorea associated with Huntington’s as early as 2 weeks

Key takeaways:

• The FDA approved Ingrezza due to results from KINECT-HD, a phase 3, randomized, double-blind, placebo-controlled clinical trial.
• New analysis revealed greater improvement in chorea at the lowest approved dose.

A Southern California-based bioscience firm has announced additional positive data on FDA-approved Ingrezza capsules to treat adults with chorea associated with Huntington’s disease.

According to a company release, exploratory results from the phase 3 KINECT-HD study found Ingrezza (valbenazine, Neurocrine Biosciences) demonstrated improvements in HD chorea compared with placebo as early as week 2 of treatment and sustained that improvement through week 12.

Updated data on KINECT-HD was to be presented at the International Congress of Parkinson's Disease and Movement Disorders in Copenhagen. “The exploratory analysis from our KINECT-HD study further exemplifies the value of Ingrezza as a now approved medication for HD chorea with improvements seen with treatment as early as two weeks,” Neurocrine’s Chief Medical Officer Eiry W. Roberts, MD, said in the release.

The FDA approved Ingrezza on Aug. 21 in large part due to results from KINECT-HD, a phase 3, randomized, double-blind, placebo-controlled clinical trial. The study met its primary endpoint of chorea reduction measured by Unified Huntington’s Disease Rating Scale Total Maximal Chorea (UHDRS-TMC) score with a placebo-adjusted improvement of 3.2 points by week 12, per the release. New analysis of the study revealed greater placebo-adjusted improvement in chorea at the lowest approved dose of 40 mg as early as the first treatment visit at week 2, the company also revealed.

According to statistics cited in the release, significantly greater improvements in secondary endpoints were found at 12 weeks of treatment compared with placebo in both Clinical Global Impression of Change (CGI-C; 42.9% vs. 13.2%, respectively) and Patient Global Impression of Change (PGI-C; 52.7% vs. 26.4%, respectively).

“This exploratory analysis has increased our insight regarding the early and sustained improvements in chorea severity,” Erin Furr Stimming, MD, FAAN, FANA, KINECT-HD principal investigator and Huntington Study Group and professor of neurology at McGovern Medical School at UTHealth Houston, said in the release.