Neurocrine Biosciences Presents Additional Phase 3 Data for KINECT-HD Study Evaluating Valbenazine for Chorea Associated with Huntington Disease at HSG 2022

SAN DIEGO, Nov. 3, 2022 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX), a leading neuroscience-focused biopharmaceutical company, today reported additional results from the Phase 3 KINECT-HD study investigating valbenazine for the treatment of chorea associated with Huntington Disease (HD). In December 2021, Neurocrine previously reported that once-daily administration of valbenazine was well tolerated with a statistically significant improvement in chorea associated with HD compared with placebo, along with substantial clinician- and patient-rated global improvement. The additional data includes an exploratory analysis of valbenazine effects over time, dosages at the end of the study, and detailed information about treatment-emergent adverse events (TEAEs) and safety parameters, such as electrocardiogram (ECG) and laboratory tests. These data (Poster #2: Valbenazine for the Treatment of Chorea Associated with Huntington Disease: Results from a Phase 3 Trial) will be shared at the 29th annual meeting of the Huntington Study Group in Tampa, Florida on November 3–5.

The KINECT-HD study met its primary endpoint of change in chorea severity using the Total Maximal Chorea (TMC) score of the UHDRS® from screening period baseline to maintenance period. Improvement in the TMC score was significantly greater with valbenazine versus placebo. The secondary endpoints of Clinical Global Impression of Change (CGI-C) Response Status and Patient Global Impression of Change (PGI-C) Response Status also significantly favored valbenazine treatment. Treatment emergent adverse events, including somnolence, fatigue, fall, and akathisia, were mild to moderate and consistent with the known safety profile of valbenazine. No suicidal behavior or worsening of suicidal ideation was observed in the valbenazine-treated subjects in this study.

"The additional findings of the Phase 3 KINECT-HD study presented in this poster demonstrate an improvement in chorea over time, with an increase in responder rates in the TMC primary endpoint, and CGI-C and PGI-C outcomes by study visit up to Week 12," said Eiry W. Roberts, M.D., Chief Medical Officer. "Data from the KINECT-HD and the ongoing KINECT-HD2 study formed the basis for our recent supplemental new drug application (sNDA) submission to the U.S. Food and Drug Administration."

The poster presents KINECT-HD data of valbenazine compared with placebo at Week 12, showing a placebo-adjusted lean-squares mean change (LSM) reduction of 3.2 units (p<0.0001) in the TMC primary endpoint, and a reduction in the secondary endpoints of 42.9% vs 13.2% (p< 0.001) reduction for CGI-C, 52.7% vs 26.4% (p<0.01) reduction for PGI-C. Secondary endpoints for Quality of Life in Neurological Disorders (NeuroQoL) for upper and lower extremity function did not reach statistical significance. Incidence of TEAEs was comparable between treatment groups (valbenazine vs placebo), including any TEAE (76.6% vs 63.5%); serious TEAEs (1.6% vs 3.2%); and discontinuation due to TEAEs (7.8% vs 6.3%). No clinically important changes in vital signs, ECG, or laboratory tests were found. In this study, no suicidal behavior or worsening of suicidal ideation was reported as a TEAE or per the C-SSRS in valbenazine-treated participants.