Huntington Study Group Welcomes FDA Approval of New Drug for Chorea in Huntington's Disease

- Changes Made to Rochester, NY: August 18, 2023

(HSG) along with its completely owned subsidiary,

Huntington's disease (HD) - a renowned authority in medical research - unveils the latest developments in their groundbreaking clinical trials. They proudly present the results of the Phase 3 pivotal study named KINECT®-HD, which was carried out in partnership with HSG.

The endorsement given by the Food and Drug Administration (FDA) to Neurocrine's medication called valbenazine for addressing the condition of uncontrollable body movements linked to Huntington's disease is a significant development. The Huntington Study Group (HSG) has played a vital role in conducting three essential trials that have ultimately resulted in FDA approval for medications targeting this particular disease.

Hubbard explains that chorea can greatly impair daily activities due to its irregular and excessive uncontrollable movements.

Dr. [Neurologist's Name], a renowned professional specializing in neurology at UTHealth Houston, a devoted member of the Huntington Study Group (HSG), and the main researcher leading the KINECT-HD study, emphasized the utmost significance of having more treatment alternatives for individuals affected by HD. Furthermore, Dr. [Neurologist's Name] expressed deep appreciation towards the generous participation of HD study volunteers, as their invaluable contribution has enabled the availability of this innovative therapeutic approach.

The KINECT-HD trial achieved its main and additional goals by demonstrating that valbenazine, an innovative inhibitor of the vesicular monoamine transporter 2 (VMAT2), effectively diminished symptoms of chorea associated with HD within just two weeks of the first treatment. Additionally, valbenazine proved to be highly tolerable in the KINECT-HD study.

, MD, the top medical executive at HSG expressed great satisfaction with our partnership alongside Neurocrine, which has resulted in this significant research.

the country. The aim of the study was to evaluate the effectiveness of KINECT-HD, a new medication for treating a specific condition. The participants were divided into two groups: one group received the actual medication, while the other group received a placebo. Neither the participants nor the researchers knew which group they were in, as the study was designed to be double-blind. The study took place at 46 different medical sites that are part of the HSG network. The goal was to gather information from a wide range of participants in order to ensure accurate results.

and Center for Coordination of Clinical Trials (CCCT)

addition, the research involved the utilization of a unique tool for patients to self report their outcomes, known as the Huntington's Disease Health Index (HD-HI), along with a sub study utilizing sensors. The comprehensive findings of the research were published in The Lancet Neurology journal.

The Chief Executive Officer (CEO) of HSG expressed gratitude towards the individuals who took part in the study, their loved ones, as well as the HSG locations for their valuable support towards KINECT-HD.

Neurocrine made an official announcement today about the approval granted by the FDA. You can check out the details of this announcement on their website here: https://www.neurocrine.com/news-and-media/.

We will be sharing the latest information on the KINECT-HD studies during HSG's Annual Meeting.

The KINECT®-HD2 study is currently being conducted to assess the safety and tolerance of INGREZZA in patients with HD chorea over a long period of time. Additionally, the study aims to evaluate how well the effects of INGREZZA can be maintained in these patients.

Introduction: Huntington’s Disease (HD) is a genetic disorder that causes gradual damage to the brain and affects a person's ability to move, think, and experience stable mental health. It is a condition that progresses over time, leading to movement difficulties, psychiatric challenges, and cognitive changes. Typically, HD symptoms emerge in adulthood, but they can start at any age. Although HD is a rare condition, with only around 200,000 diagnosed cases globally, many individuals remain at risk of inheriting the disease from their parents. It is important to note that Huntington’s disease does not discriminate and can affect people of all genders, races, and ethnic backgrounds. While there are treatments available to manage the symptoms, a definitive cure for HD is yet to be found.

HSG, a non-profit entity established in 1993 in

, along with its entirely possessed subsidiary,

HSG organizes and carries out scientific experiments globally under the world's premier and most extensive collective system, comprising numerous participants across over 130 authorized research establishments. HSG is fully committed to enhancing the quality of life for individuals affected by Huntington's disease by means of exploring, educating, and collaborating. For additional details, please visit www.huntingtonstudygroup.org.

The Clinical Trials Coordination Center at is a facility dedicated to managing and overseeing clinical trials. This center provides a wide range of services to support the various stages of the research process. At the facility, there are experienced professionals who specialize in coordinating clinical trials. These experts work closely with researchers, healthcare providers, and patients to ensure that trials are conducted ethically and efficiently. Their main goal is to facilitate the smooth execution of trials and streamline the flow of information. The center also offers assistance in designing study protocols and creating data management systems. They provide support in the recruitment and enrollment of eligible participants, as well as in the collection and analysis of data. Through their expertise, they help researchers keep track of deadlines, ensure compliance with ethical guidelines and regulatory requirements, and maintain rigorous standards of quality. Furthermore, the Clinical Trials Coordination Center aims to enhance collaboration and communication among researchers, ultimately advancing the field of clinical research. By offering educational programs and training opportunities, they help build the skills and knowledge needed to conduct successful trials. Overall, the Clinical Trials Coordination Center plays a crucial role in the research community by providing comprehensive support to researchers throughout the lifecycle of clinical trials. Their dedication and expertise contribute to the development of safe and effective healthcare interventions.

CTCC focuses on the advancement, supervision, and execution of clinical research investigations and offers a comprehensive array of support services for research and clinical trial management. These services empower the smooth progression of clinical research, starting from the inception of the study to the analysis of data, publication, and approval from the FDA. Throughout the past three decades, CTCC has successfully overseen the implementation of more than 135 clinical research studies, collaborating with 50 different sponsors from sectors such as government, industry, and private organizations. These studies have collectively enrolled over 40,000 participants within the United States.

Get in touch with the Huntington Study Group by reaching out to Kristin Keyes at 800-487-7671 or by contacting them via email. For further information, visit their website at huntingtonstudygroup.org.