Neurocrine Biosciences Presents New INGREZZA Capsules Data Demonstrating Early and Sustained Improvements

Neurocrine (NASDAQ:NBIX) Biosciences, Inc. (Nasdaq: NBIX) today announced new data on now FDA-approved INGREZZA^® (valbenazine) capsules for the treatment of adults with chorea associated with Huntington's disease (HD), including exploratory results from the Phase 3 KINECT^®-HD study, which showed consistently greater improvements in HD chorea with INGREZZA versus placebo from Week 2 to Week 12. These data will be presented at the MDS International Congress of Parkinson's Disease and Movement Disorders^® August 27-31 in Copenhagen, Denmark.

"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," said Eiry W. Roberts, M.D., 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 Unified Huntington's Disease Rating Scale (UHDRS^®) Total Maximal Chorea (TMC) scores that signal clinically meaningful chorea improvements."

KINECT-HD, a Phase 3, randomized, double-blind, placebo-controlled study met its primary endpoint of chorea reduction as assessed using the UHDRS TMC score with a placebo-adjusted improvement of 3.2 points at Week 12 among those receiving INGREZZA. Secondary endpoints also demonstrated significantly greater improvements at Week 12 (ratings of "much improved" or "very much improved") among those treated with INGREZZA compared with placebo as assessed using the Clinical Global Impression of Change (CGI-C; 42.9 percent versus 13.2 percent, respectively) and Patient Global Impression of Change (PGI-C; 52.7 percent versus 26.4 percent, respectively). These findings were recently published in The Lancet Neurology.

The new exploratory analysis of KINECT-HD (Chorea Improvements Over Time With Once-Daily Valbenazine Treatment In Adults With Huntington Disease, poster # 879) showed greater placebo-adjusted improvement in chorea with INGREZZA at the lowest dose (40 mg) as early as the first treatment visit (Week 2), and greater efficacy compared to placebo was sustained through Week 12. The percentage of participants rated "much improved" or "very much improved" by CGI-C and PGI-C was consistently higher with INGREZZA than with placebo at all study visits.

"The KINECT-HD study has provided valuable data regarding the safety and efficacy of INGREZZA for HD chorea in adults, and we continue to look at the data in new ways," said Erin Furr Stimming, M.D., FAAN, FANA, Principal Investigator, Huntington Study Group and Professor of Neurology at McGovern Medical School, UTHealth Houston. "This exploratory analysis has increased our insight regarding the early and sustained improvements in chorea severity."

Additional HD chorea presentations at the MDS International Congress of Parkinson's Disease and Movement Disorders include:

• A Minimal Clinically Important Difference for UHDRS Total Maximal Chorea Score as a Measure of Chorea Severity in Huntington Disease (poster # 880)
• Indirect Treatment Comparison of Valbenazine with Deutetrabenazine for Improvement in Total Maximal Chorea Score in Huntington Disease (poster # 890)

The full abstracts presented by Neurocrine Biosciences at the MDS International Congress of Parkinson's Disease and Movement Disorders are available on the meeting website and can be accessed by registering.