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SAN DIEGO , Aug. 5, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX ), in collaboration with the Huntington Study Group , today announced the completion of patient enrollment for its Phase 3 ( KINECT-HD ) clinical study evaluating the efficacy, safety and tolerability of valbenazine, a selective, orally active vesicular monoamine transporter 2 (VMAT2) inhibitor being investigated as a once-daily treatment in adults with chorea in Huntington disease. A top-line data readout of the clinical study results is anticipated by the end of 2021.
"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 Neurocrine Biosciences. "I'd like to thank our partners at the Huntington Study Group, the Clinical Trials Coordination Center at the University of Rochester , New York, the KINECT-HD investigative staff, and especially the patients and families for their commitment and perseverance in completing enrollment in the face of all the challenges posed by the pandemic."
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 the United States . Chorea, an involuntary movement disorder, in which people develop abnormal, abrupt or irregular movements, is one of the most common symptoms, affecting roughly 90% of those diagnosed. Current treatments available for chorea are associated with increased risk of depression and suicidality.
"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 Andrew Feigin , M.D., Chair of the Huntington Study Group. "We are grateful for our partnership with Neurocrine Biosciences and the possibility of improving the lives of people living with this condition."
Valbenazine was discovered and developed by Neurocrine Biosciences to address the unmet medical needs of people suffering from hyperkinetic movement disorders and was approved by the United States Food and Drug Administration (FDA) in April 2017 for the treatment of adults with tardive dyskinesia. Neurocrine Biosciences is also investigating valbenazine as an adjunctive treatment for schizophrenia and for the treatment of dyskinesia due to cerebral palsy.
About KINECT-HD 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 .
About KINECT-HD2 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.
About Huntington Study Group Founded in 1993 in Rochester, NY , the Huntington Study Group (HSG) is a not-for-profit organization comprised of the world's first and largest collaborative network of experts in Huntington disease (HD). The mission of the HSG is seeking treatments that make a difference for those affected by HD. With more than 800 credentialed HD experts at over 130 HSG credentialed research sites worldwide, the HSG is a leader in conducting clinical trials for 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 .
About Neurocrine Biosciences Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com , and follow the company on LinkedIn . (*in collaboration with AbbVie)
SOURCE Neurocrine Biosciences, Inc.