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Rochester, NY August 18, 2023 –(PR.com)– The Huntington Study Group (HSG) together with its wholly owned subsidiary, HSG Clinical Research, Inc., a world leader in clinical trials for Huntington’s disease (HD), today shares that the Phase 3 pivotal KINECT®-HD study conducted by HSG in collaboration with Neurocrine Biosciences, Inc. resulted in the U.S. Food and Drug Administration’s (FDA) approval of Neurocrine’s drug, valbenazine, for the treatment of chorea associated with HD. HSG has been instrumental in all three pivotal clinical trials that have led to FDA approved medications for Huntington’s disease.
Chorea, the hallmark motor symptom of HD, described as irregular, excessive involuntary movements can severely negatively impact day-to-day life. Dr. Erin Furr Stimming, Neurologist at UTHealth Houston, longtime HSG member, and Principal Investigator of the KINECT-HD study said, “It is incredibly important to have additional therapeutic options for people with HD, and we are extremely grateful to our HD study participants for helping us make this new treatment available.”
The KINECT-HD study met primary and secondary endpoints, showing that valbenazine, a novel vesicular monoamine transporter 2 (VMAT2) inhibitor, reduced HD-related chorea symptoms as early as two weeks after the initial dose. In KINECT-HD, valbenazine was also well tolerated. Andrew Feigin, MD, Chief Medical Officer of HSG said, “We are immensely proud of our collaboration with Neurocrine that led to this important study.”
KINECT-HD was a randomized double-blind, placebo-controlled study with 128 participants at 46 HSG sites across North America conducted by Huntington Study Group in collaboration with Neurocrine Biosciences, Inc. and Clinical Trials Coordination Center (CTCC)/Center for Health + Technology (CHeT) at the University of Rochester Medical Center. The study also included the use of a novel patient reported outcome measure, Huntington’s Disease Health Index…
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