Neurocrine Biosciences Announces Completion of Enrollment in Phase 3 KINECT-HD Study Evaluating Valbenazine for Chorea in Huntington Disease
"This milestone reflects the progress that we have made in advancing valbenazine as a potential treatment for people living with chorea in Huntington disease and we look forward to sharing top-line results later this year," said Eiry W. Roberts, M.D., Chief Medical Officer at
Participants who have completed KINECT-HD can enroll in KINECT-HD2, an open-label extension study to evaluate the long-term safety and tolerability of valbenazine for the treatment of chorea in Huntington disease. The KINECT-HD2 study is now also open to new patients who have not participated in the KINECT-HD study.
Huntington disease impacts an estimated 30,000 adults in
"We're pleased to be part of these clinical studies and to see valbenazine move forward in its development as a potential therapy for people living with chorea in Huntington disease," said
Valbenazine was discovered and developed by
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); evaluate the safety and tolerability of valbenazine in patients with HD; and evaluate the ability of wearable movement sensors to detect changes in physical activity (optional activity). The study enrolled adults 18 to 75 years of age who have been diagnosed with motor manifest HD and whom 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, extension study to evaluate the long-term safety and tolerability of valbenazine in patients with chorea in Huntington disease (HD). The 112-week study enrolls adults 18 to 75 years of age who have been diagnosed with motor manifest HD and whom have sufficient chorea symptoms to meet study protocol criteria. For more information on the KINECT-HD2 study, please visit clinicaltrials.gov.
About Chorea in Huntington Disease
Huntington disease (HD) is a hereditary progressive 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, in which people develop abnormal, abrupt or irregular movements. Chorea can affect various body parts and interfere with speech, swallowing, posture and gait. HD is estimated to affect approximately 30,000 adults in the U.S., with more than 200,000 at risk of inheriting the disease. Current treatments available for chorea are associated with increased risk of depression and suicidality.
Founded in 1993 in
Neurocrine Biosciences Forward-Looking Statements
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: 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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