Rochester, NY, August 18, 2023 - 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 (HD-HI), and a sensor sub study. The complete results of the study were published in The Lancet Neurology in June 2023.
Shari Kinel, CEO of HSG said, “We would like to thank the study participants, their families, and HSG sites for their support of KINECT-HD.”
Neurocrine issued a press release today announcing the FDA approval. The press release can be found on their website at https://www.neurocrine.com/news-and-media/.
Neurocrine Biosciences, Inc. will be providing an update on the KINECT-HD studies at HSG’s Annual Meeting on November 2-4, 2023, in Phoenix, Arizona. KINECT®-HD2 is an ongoing open-label study to evaluate the long-term safety and tolerability, as well as the maintenance of effects of INGREZZA in patients with HD chorea.
About Huntington’s Disease
Huntington’s disease (HD) is a progressive hereditary neurodegenerative disease characterized by movement disorders, psychiatric difficulties, and cognitive changes. HD symptoms usually present in middle adult life but can begin at any age. HD is a rare disorder -- about 200,000 people worldwide have been diagnosed but many more are at risk for inheriting the disease from a parent. Huntington’s disease impacts people of all genders, races, and ethnicities. While symptomatic treatments are available, a cure for HD has not yet been discovered.
About Huntington Study Group / HSG Clinical Research, Inc.
The Huntington Study Group (HSG), a not-for-profit organization founded in 1993 in Rochester, NY, and its wholly owned subsidiary, HSG Clinical Research, Inc., designs and conducts clinical trials through the world’s first and largest collaborative network with thousands of members at more than 130 HSG credentialed research sites worldwide. HSG is dedicated to improving the lives of people impacted by Huntington’s disease through research, education, and collaboration. For more information, visit www.huntingtonstudygroup.org.
About Clinical Trials Coordination Center at University of Rochester Medical Center
CTCC specializes in the development, management, and conduct of clinical research studies and provides a full range of research and clinical trial management support services that facilitate the conduct of clinical research from study concept through data analysis, publication, and FDA approval. Over the past 30 years, the CTCC has managed the conduct of more than 135 clinical research studies with 50 sponsors (government, industry & private) that enrolled over 40,000 research participants in US, Canada, Europe, New Zealand, and Australia.
Contact
Huntington Study Group
Kristin Keyes
800-487-7671
https://huntingtonstudygroup.org
