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.
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.
Enrollment continues in the KINECT-HD2 open-label study to evaluate the long-term safety and tolerability of valbenazine for the treatment of chorea in Huntington Disease.
KINECT-HD is a Phase 3, randomized, double-blind, placebo-controlled study designed to: evaluate the efficacy of valbenazine as a once-daily treatment to reduce chorea associated with Huntington disease (HD) and evaluate the safety and tolerability of valbenazine in patients with HD. The study enrolled 128 adults 18 to 75 years of age who have been diagnosed with motor manifest HD and who have sufficient chorea symptoms to meet study protocol criteria. For more information on this KINECT-HD study, please visit www.huntingtonstudygroup.org.
KINECT-HD2 is an open-label study to evaluate the long-term safety and tolerability of valbenazine in patients with chorea associated with Huntington disease (HD). The 158-week study is enrolling up to 150 adults 18 to 75 years of age who have been diagnosed with motor manifest HD and who have sufficient chorea symptoms to meet study protocol criteria. For more information on the KINECT-HD2 study, please visit www.huntingtonstudygroup.org or clinicaltrials.gov.
Huntington disease (HD) is a hereditary progressive, ultimately fatal neurodegenerative disorder in which neurons within the brain break down, resulting in motor, cognitive and psychiatric symptoms. Symptoms generally appear between the ages of 30 to 50 and worsen over a 10- to 25-year period. Many people with HD experience chorea, a troublesome involuntary movement disorder, characterized by irregular and unpredictable movements. Chorea can affect various body parts and interfere with motor coordination, gait, posture, swallowing, and speech. HD is estimated to affect approximately 40,000 adults in the
Founded in 1993, the Huntington Study Group (HSG), a global not-for-profit organization, together with its wholly owned for-profit subsidiary, HSG Clinical Research, Inc., designs, implements, manages, and conducts clinical research trials. The HSG, a leader in conducting clinical trials for HD, has more than 800 HD experts at over 130 HSG Credentialed Research Sites worldwide. The mission of the HSG is seeking treatments that make a difference for those affected by HD. The HSG also offers educational services like CME4HD™ for healthcare professionals and care providers on treating patients with HD. For more information, visit our website www.huntingtonstudygroup.org.
The KINECT-HD study was conducted in cooperation with the HSG and the Clinical Trials Coordination Center (CTCC) at the University of Rochester Medical Center's Center for Health + Technology (CHeT). For more information, visit the CTCC website https://www.urmc.rochester.edu/health-technology/our-expertise/clinical-trials-coordination.aspx.
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In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from the Company's products and product candidates. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements include: risks and uncertainties associated with valbenazine development for chorea in Huntington disease (HD), that valbenazine development activities may not be completed on time or at all; risks that valbenazine development activities may not be completed or may be delayed for regulatory or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that valbenazine is safe, tolerable or effective in the chorea in Huntington disease (HD) population, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that regulatory submissions may not occur or be submitted in a timely manner; risks that valbenazine may not obtain regulatory approval for chorea in Huntington disease (HD), or that the
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Neurocrine Biosciences, Inc., Media, Linda Seaton, 1-858-617-7292, media@neurocrine.com; Investors, Todd Tushla, 1-858-617-7143, ir@neurocrine.com