Press Releases

Rochester, NY – December 5, 2022 – The Huntington Study Group (HSG), a world leader in conducting clinical trials for Huntington’s Disease (HD), through its Clinical Research Organization (CRO), HSG Clinical Research, Inc. (HSGCR), continues making groundbreaking progress in the HD world. At their Annual Meeting in November, the HSG team presented exciting updates about their Clinical Research Organization’s achievements.

There were many notable highlights, including information about two current HSG clinical trials. The KINECT-HD/KINECT-HD2 trials, sponsored by Neurocrine Biosciences, Inc. (NBI), met enrollment goals and continued study activities during COVID-19. It was announced during the meeting that the KINECT-HD trial met its primary endpoint of change in chorea severity using the Total Maximal Chorea (TMC) score of the UHDRS® from screening period baseline to maintenance period. Improvement in the TMC score was significantly greater with Valbenazine versus placebo. KINECT-HD2 is an open-label trial that is currently enrolling subjects.

Erin Furr-Stimming, MD, the Principal Investigator of the KINECT studies, said,  “The strong partnership between HSG and NBI was instrumental in facilitating a successful symptomatic trial in HD, an important milestone advancing HD care and awareness. We are incredibly grateful to the study participants and their care partners who participated in KINECT-HD and continue to participate in KINECT-HD2.”

The Phase 3 global PROOF-HD trial, sponsored by Prilenia Therapeutics, is assessing the effect of pridopidine on function in early-stage HD subjects. The trial launched early during COVID-19 and enrolled 499 subjects over 1 year during the height of the pandemic. Andrew Feigin, MD, the North American Principal Investigator (PI) of the study and HSG’s Chief Medical Officer, said “The HSG is proud to be working with an amazing team to conduct this international multicenter clinical trial. The rapid rate of recruitment in this study during the most challenging of times speaks to the inspiring dedication, commitment, and enthusiasm of the HD community.”

The SIGNAL trial, sponsored by Vaccinex, Inc., is the first IV Infusion trial in HD and detailed results were recently published in Nature Medicine¹. This 301-subject study met enrollment goals and completed closeout ahead of schedule during COVID-19.  

Elise Kayson, MS, ANP, the VP of Clinical Operations, said, “HSGCR is committed to designing and conducting innovative HD clinical trials. Our dedicated and experienced HD centric team works closely with HSG sites to be efficient and trial ready to meet the needs of our sponsors and patients and families. HSGCR’s recent successful accomplishments speak multitudes about our capabilities as a CRO.” 

Since the HSG was founded in 1993, the organization has continually proven that they are a leader in HD clinical research. The HSG continues to innovate in clinical trial design, biomarkers, and in the operational side of HD clinical trials. Notably, the HSG conducted the clinical trials for the first and only two FDA approved drugs for HD, the first clinical trial in HD, and the first longitudinal study in HD.

“As the year comes to a close, our team is reflecting on the impact our collective efforts have made, and we’re looking forward to continuing to do everything we can to make a difference in 2023 and beyond. We would also like to extend our gratitude to all of our partners, sponsors, and collaborators who make what we do every day a possibility and a reality,” said Shari Kinel, JD, CEO.

¹Feigin, A., Evans, E.E., Fisher, T.L. et al. Pepinemab antibody blockade of SEMA4D in early Huntington’s disease: a randomized, placebo-controlled, phase 2 trial. Nat Med 28, 2183–2193 (2022). https://doi.org/10.1038/s41591-022-01919-8

HSG offers a full suite of CRO services. To learn more, please visit: https://huntingtonstudygroup.org/wp-content/uploads/HSG_Trial_Services_Sheet.pdf

About Huntington’s Disease
Huntington’s Disease (HD) is a hereditary neurodegenerative disease characterized by a movement disorder, psychiatric difficulties, and cognitive changes, usually beginning in middle adult life. About 40,000 people in North America have HD, and another 200,000 are considered “at risk” for inheriting the illness because they have (or had) a parent with HD.
 
About Huntington Study Group / HSG Clinical Research
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’s Disease whose mission is to seek treatments that make a difference for those affected by HD. HSG Clinical Research, Inc., a wholly owned subsidiary of the HSG, is a full-service clinical research organization that specializes on conducting trials in HD. There are over 800 HD experts at more than 130 HSG credentialed research sites worldwide. The HSG also offers educational services like CME4HD™ for healthcare professionals and care providers on treating patients with HD. For more information, visit www.huntingtonstudygroup.org.

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Rochester, NY — January 10, 2023 — The Huntington Study Group (HSG), a world leader in clinical research for Huntington’s Disease (HD) for over 30 years, today announced Brett Kinsler has been named to the newly created position of Chief Innovation Officer (CINO). Kinsler will build on HSG’s remarkable history of mission-focused, transformative advances in clinical trial work related to HD. “We created this role knowing our organization would benefit greatly from a champion who could generate and cultivate ideas and guide their successful implementation,” said Shari Kinel, Chief Executive Officer of HSG. “We know Brett is the right person, in part due to his previous experience with HSG.”

Last year, Kinsler served as a consultant to develop HSG’s myHDstory™, an online platform that allows the HD community to contribute to research remotely. “The development and implementation of this platform were key to the success of our pilot observational study, ‘Making HD Voices Heard.’ We owe the ease of participation in our study in large part to Brett and the structured thinking he brought to the team,” said Dr. Karen Anderson, MD, Professor of Psychiatry and Neurology at Georgetown University Medical Center and Principal Investigator of the study. Brett will also be an instrumental part of the organization’s plans to create a comprehensive education center dedicated to enhancing the knowledge and capabilities of HSG members, families, and sponsors to improve research and care. The formation of this center is another example of how HSG continues to lead, innovate, and grow.

Kinsler’s broad background, which includes experience in clinical trials, clinical practice, entrepreneurialism, post-graduate teaching, and strategic advisory for hospitals, health systems, payers, collaboratives, federal and state governments are a natural fit for HSG and its wholly owned clinical research subsidiary, HSG Clinical Research, Inc. 

“I’m so excited to join the amazing HSG team in their mission to discover treatments that matter to people affected by HD,” Kinsler said. “I love applying strategic thinking, technology, and innovation to develop new solutions and processes that drive better outcomes. HSG is at the forefront of HD research and is making history with its many firsts. I cannot wait to be a part of that and help HSG continue to grow as a leader in HD research, education, and care.”

Kinsler began as the new CINO on January 9, 2023.

About Huntington’s Disease
Huntington’s Disease (HD) is a hereditary neurodegenerative disease characterized by a movement disorder, psychiatric difficulties, and cognitive changes, usually beginning in middle adult life. About 30,000 people in North America have HD, and another 200,000 are considered “at risk” for inheriting the illness because they have (or had) a parent with HD. 

About Huntington Study Group / HSG Clinical Research
Founded in 1993 in Rochester, NY, the Huntington Study Group (HSG) is a not-for-profit organization comprising the world’s first and largest collaborative network of experts in Huntington’s Disease whose mission is to seek treatments that make a difference for those affected by HD. HSG Clinical Research, Inc., a wholly-owned subsidiary of the HSG, is a full-service clinical research organization that specializes in conducting HD trials.  There are 700 credentialed HD experts at more than 120 HSG credentialed research sites worldwide.  The HSG also offers educational services such as CME4HD™ for healthcare professionals and care providers treating patients with HD. For more information, visit www.huntingtonstudygroup.org.

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Rochester, N.Y.  — October 12, 2022 — The Huntington Study Group (HSG), a world leader in conducting clinical trials for Huntington’s Disease (HD) for over 30 years, together with its Clinical Research Organization (“CRO”), the HSG Clinical Research, Inc., today announces the enrollment of the first participant of its novel and innovative observational study, Virtual Unified Huntington’s Disease Rating Scale (vUHDRS®), assessing the reliability of a virtual use of the HSG’s standard assessment tool, the Unified Huntington’s Disease Rating Scale (UHDRS®). The first participant was enrolled at Hereditary Neurological Disease Centre in Wichita, KS.

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The Huntington Study Group (HSG) is pleased to announce the that Dr. Nicolò Zarotti has been named recipient of the Peter Como Scholarship to attend the renowned annual meeting.

Dr. Zarotti obtained his Bachelor’s and Master’s degree in Psychology in Italy, and later joined Lancaster University (UK), where he completed his PhD focused on emotional processing and communication in Huntington disease (HD). Dr. Zarotti is currently part of a team collaborating with the British Psychological Society to produce new guidance on psychological approaches to the understanding and treatment of psychological difficulties in people with motor neurodegenerative conditions such as HD.

The Peter Como Scholarship, named in memory of one of HSG’s founders and biggest supporters, is awarded annually for a professional in the mental health field to attend HSG 2018: Unlocking HD. The Como Scholarship includes two nights’ lodging, travel funding, and a modest stipend.

The Huntington Study Group was formed in 1993 and is the world’s first HD cooperative therapeutic research organization. Twenty-five years later, HSG is a world leader in facilitating high quality clinical research trials and studies that work toward finding effective treatments for HD. HSG has the first and largest HD clinical research network of more than 400 active and compassionate investigators, coordinators, scientists and HD experts at more than 120 credentialed research sites around the globe. HSG members are world experts in caring for individuals and families impacted by Huntington disease. Visit https://huntingtonstudygroup.org/ for more information.

JAMA publishes First-HD study

People with Huntington disease experienced improvements in chorea while taking deutetrabenazine (SD-809) compared to placebo, according to a paper published today in the Journal of the American Medical Association (JAMA). Although the topline results of the trial have been released previously, the complete peer-reviewed publication about the First-HD clinical trial is now published in a premier medical journal.

Deutetrabenazine was investigated in the First-HD study, a Phase 3 clinical trial which was led by the Huntington Study Group (HSG) on behalf of Teva Pharmaceuticals. In the double-blind, placebo-controlled trial, deutetrabenazine significantly decreased chorea, the involuntary movements that many individuals with HD experience.

“Patients’ chorea and motor scores improved compared to placebo over the course of 12 weeks,” said Samuel Frank, MD, HSG’s principal investigator of First-HD and director of the HDSA Center of Excellence at Beth Israel Deaconess Medical Center in Boston. “In addition, both the participants and their study physicians reported overall improvement.”

First-HD enrolled 90 patients at 34 HSG research sites between August 2013 and August 2014. The trial followed patients for 12 weeks on the medication and measured their chorea, as well as patients’ and clinicians’ impression of improvement.

Frank

“As a physician who cares for people with HD, it’s gratifying to see positive results from a well-designed, fully enrolled trial. Until we find a cure, we aim to bring our patients more treatment options to relieve symptoms,” Frank said. “We are grateful to the people who participated in this trial and their families and support systems that made their participation possible. Research in the HD community depends on volunteers enrolling in trials.”

At the end of May, Teva Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) asked for more data on deutetrabenazine, which had been under review to treat chorea associated with HD. The request for more data is common when the FDA is asked to approve new medications, and this is the first deuterated compound to be reviewed by the FDA. Michael Hayden, M.D., Ph.D., Teva’s president of Global R&D and chief scientific officer said Teva plans to respond to the request in the third quarter of 2016.

There is only one drug currently approved to treat chorea associated with Huntington disease: tetrabenazine. Deutetrabenazine is structurally related to tetrabenazine with deuterium atoms placed at key positions in the molecule, prolonging plasma half-life and reducing metabolic variability, without changing target pharmacology. This can translate into effective symptom control with fewer medication doses a day, lower total daily doses, and improved tolerance. In First-HD, both patient and clinician overall assessments were significantly better in the deutetrabenazine treated group compared to placebo after 3 months. The deutetrabenazine group improved in a quality of life measure while the placebo group worsened.

Testa

“Overall status and quality of life measures are especially relevant in chorea, where no single number captures what is clinically meaningful to patients themselves,” said Claudia Testa, MD, PhD, HSG’s co-principal investigator for First-HD and director of the HDSA Center of Excellence at Virginia Commonwealth University. “It’s exciting to see how treating an HD symptom can make a real-life positive impact.”

Much of the work that led to the completion of the First-HD trial was carried out by the HSG, a non-profit network of 400 Huntington disease experts from more than 100 medical centers throughout North America, Europe, Australia, New Zealand, and South America who are dedicated to seeking treatments that make a difference for people and families affected by the disease. For more information about the Huntington Study Group, visit www.huntingtonstudygroup.org.

Scientific, technical, logistical, and analytical support for First-HD was provided by the University of Rochester Clinical Trials Coordination Center (CTCC). The Clinical Trials Coordination Center is part of the Center for Human Experimental Therapeutics (CHET) and is a unique academic-based organization with decades of experience working with industry, foundations, and governmental researchers in bringing new therapies to market for neurological disorders.  For more information about the Clinical Trials Coordination Center, visit http://www.ctcc.rochester.edu.

Teva Pharmaceutical acquired deutetrabenazine through its purchase of Auspex Pharmaceuticals last year. Deutetrabenazine is an investigational, oral, small-molecule inhibitor of vesicular monoamine 2 transporter, or VMAT2, that was granted Orphan Drug Designation for the treatment of HD by the FDA.

A second deutetrabenazine trial, ARC-HD, which has completed enrollment, is investigating the safety, efficacy, and tolerability of the drug when individuals with HD switch from tetrabenazine to deutetrabenzine and the safety of longer term exposure. This trial, which includes participants who completed First-HD, is also being led by the HSG and the Clinical Trials Coordination Center for Teva Pharmaceutical Industries. Teva is also investigating the potential of deutetrabenazine to treat tardive dyskinesia, a disorder that causes involuntary and repetitive movements, and for tics associated with Tourette syndrome.