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Huntington Study Group Announces Call for Abstracts for the 30th Annual Meeting

Rochester, NY – June 1, 2023 – The Huntington Study Group (HSG), with a mission of accelerating treatments that make a difference for those impacted by Huntington’s disease, together with its wholly owned subsidiary, HSG Clinical Research, Inc., a world leader in conducting clinical trials for Huntington’s disease (HD), today announces that the submission period has begun for abstracts to be considered for presentation at their 30th annual meeting in November (“HSG 2023”).

For decades at their Annual Meeting, HSG has provided an opportunity for researchers to present valuable findings and information about HD clinical research to event attendees through poster sessions and platform presentations during the Peter Como HD Research Symposium. Dr. Como, one of the founders of HSG, dedicated his life to advancing research and promoting the sharing of new knowledge about Huntington’s disease.

All abstracts accepted by HSG’s Publications Committee will be presented by the authors at HSG 2023 during multiple poster viewing sessions throughout the meeting, printed in a program provided to all meeting attendees, and published in the Journal of Huntington Disease (JHD). In addition, two abstract authors will be selected to formally present their research during a plenary session.

Dr. Erin Furr-Stimming, Co-Chair of HSG’s Publications Committee, said, “I have served on the Publications Committee since 2016 and have been incredibly impressed with the quality of the abstracts submitted. I always look forward to reviewing the exceptional science and innovation focused on advancing our understanding and treatment options for HD.”

The deadline for abstract submission is July 31, 2023. Eligible abstracts may include data that has been presented previously, though it should still be of public and scientific interest. Authors will be asked to disclose relationships with funding sources and manufacturers of commercial products discussed in the presentations. Abstract authors do not need to be HSG members. To learn more or submit your research for consideration, visit https://www.judgify.me/HSG2023.

If you would like to sponsor this year’s poster sessions, please contact us at info@hsglimited.org. For general sponsorship opportunities for the HSG 2023 annual meeting, please click here.

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.

To read the full press release, click here.

Neurocrine Biosciences Announces Publication of Full KINECT™-HD Phase 3 Study Results of Valbenazine for the Treatment of Chorea Associated with Huntington’s Disease in The Lancet Neurology

Statistically Significant Improvement in Chorea Associated with Huntington’s Disease Seen as Early as Week 2
Chorea Improvement Supported by Statistically Significant Clinical Global Impression of Change (CGI-C) Response Status and Patient Global Impression of Change (PGI-C) Response Status Scores at Week 12
First Phase 3 Study to Implement Huntington’s Disease Health Index (HD-HI), a Patient-Reported Outcome Measure, Showed Reduced Disease Burden as Reported by Patients Receiving Valbenazine versus Placebo
Supplemental New Drug Application (sNDA) Filed, with Prescription Drug User Fee Act (PDUFA) Target Date Set for August 20, 2023

Neurocrine Biosciences, Inc. today announced that the complete study results from its Phase 3 KINECT™-HD study investigating valbenazine for the treatment of chorea associated with Huntington’s disease (HD) has been published in The Lancet Neurology online edition and will appear in the June 2023 print issue. The study met its primary and secondary endpoints, demonstrating a reduction in chorea symptoms associated with HD and improvement of overall chorea severity as noticed by clinicians and patients, with improvement seen as early as Week 2 of the initial dose in the 12-week study.

The KINECT-HD randomized double-blind, placebo-controlled Phase 3 study was conducted with 128 participants at 46 Huntington Study Group (HSG)–credentialed sites in North America.

The primary endpoint was a reduction in severity of chorea, the cardinal motor feature in HD, as measured by change in the HSG-developed Unified Huntington’s Disease Rating Scale (UHDRS^®) Total Maximal Chorea (TMC) score from baseline to the average score at weeks 10 and 12. The TMC score is part of the motor assessment of the UHDRS that measures chorea.

To read the full press release, click here.

Huntington Study Group Achieves Last Patient Last Visit for Its Observational Study to Test Virtual Use of the Unified Huntington’s Disease Rating Scale®

Rochester, NY – May 16, 2023 – The Huntington Study Group (HSG) together with its wholly owned subsidiary, HSG Clinical Research, Inc., announces an important milestone in the novel observational study Virtual Unified Huntington’s Disease Rating Scale (vUHDRS™). The last participant completed the last visit, marking study completion.

The purpose of this study is to determine the reliability of administering all sections of the Unified Huntington’s Disease Rating Scale (UHDRS^®) virtually compared to in-person for clinical and clinical trial use. The UHDRS^® is the gold-standard in assessing motor function, cognitive function, behavioral abnormalities, and functional capacity in Huntington’s disease (HD). Since the tool was originally developed in 1993, the HSG-owned instrument has been used in part or in total as the primary endpoint in many HD trials. The changing face of clinical trials is prompting the need for reliable tools for assessing and interacting with patients and research participants remotely. This need became clearer and more urgent during the COVID-19 pandemic, accelerating HSG’s development of this study.

vUHDRS™ has the potential to positively impact care delivery and clinical trial operations as part of remote and hybrid trials, effectively removing some of the barriers people face when participating in research studies. This study could also increase data availability, frequency of data collection and could enhance clinical care.

Samuel Frank, MD, Associate Professor of Neurology, Director of the Huntington’s Disease Society of America Center of Excellence at Beth Israel Deaconess Medical Center, and Principal Investigator of the vUHDRS™ study, said “It’s exciting to be part of this critical study that will enhance future clinical trials in HD. We couldn’t do any of this without an incredible team and the help of our dedicated participants for whom we are so thankful.”

The vUHDRS™ study was conducted at 16 HSG sites across the US, where 60 subjects with motor manifest HD were followed over approximately six weeks through a combination of in-person and remote visits. The study team is beginning to analyze the data and hopes to announce results in third quarter 2023.

More information about this study will also be presented at HSG’s 30th Annual Meeting in November. To learn more about the meeting, including sponsorship opportunities, click here.

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 of over 800 experts in Huntington’s disease 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.

To read the full press release, click here.

HSG and HD-CAB Collaborate to Provide Global Patient Advisory Board

Rochester, NY — March 30, 2023 — The Huntington Study Group (HSG) together with its wholly owned subsidiary, HSG Clinical Research, Inc., a world leader in conducting clinical trials for Huntington’s disease (HD), recently collaborated with Huntington’s Disease – Community Advisory Board (HD-CAB) to provide a Global Patient Advisory Board on behalf of Annexon Biosciences, Inc. Annexon is a clinical-stage biopharmaceutical company whose focus is on developing a pipeline of novel therapies for patients with disorders of the body, brain, and eye that are caused by improper regulation of the body’s complement system¹.

The Advisory Board (Ad Board), held on November 30, 2022 in Jersey City, New Jersey, USA, was a six-hour session that included eleven HD-CAB advocate members from the US, Canada, Scotland, France, Italy, Sweden, Pakistan, and India, who convened to share with Annexon their stories and viewpoints and to discuss the challenges HD trial participants and their families face. One of the goals of the Ad Board was to encourage open communication about how trial sponsors and Clinical Research Organizations (CROs) can better support HD families before, during, and after clinical trials. This conversation was led by Astri Arnesen, Chair of HD-CAB and President of the European Huntington Association. Dr. Christopher Ross, HSG’s Chief Scientific Officer and Dr. Jody Corey-Bloom, Neurologist at UC San Diego and longtime HSG member, facilitated a discussion regarding Annexon’s scientific rationale in HD and planned trial design.

“HD-CAB represents the voice of the global HD community. Consisting of HD family members from six continents and 20 countries, our aim is to ensure that critical factors aren’t overlooked in the design and implementation of clinical trials. It was a pleasure to work with HSG and Annexon as they actively listened to the real-world experience of HD-CAB advocates, adjusted course as appropriate and committed to doing so on an ongoing basis,” said Astri Arnesen.

“I would like to thank the HD-CAB advocates as well as the HSG and HD-CAB management teams for the expertise and actionable next steps shared at the Global Patient Advisory Board,” said Peter Collins, VP, Global Program Team Lead of the Neurodegeneration Franchise at Annexon Biosciences. “We look forward to continued collaborations with leading patient organizations, such as HD-CAB and HSG, to ensure Annexon consistently engages with, and incorporates feedback from, the patients and families we seek to serve.”

HD-CAB recently completed a follow-up International Ad Board on behalf of Annexon Biosciences at the HYDO International Congress in Glasgow, Scotland in March 2023. HSG, HD-CAB, and Annexon Biosciences are continuing to discuss opportunities for future collaborations.

Dr. Ross noted, “HSG is always looking for innovative ways to support and engage the HD community and to make sure their voices are heard. We found this collaborative effort to be truly meaningful and hope this opportunity is just one of many that we will have the privilege of participating in. Our team is grateful to HD-CAB for their invaluable contributions and to Annexon for enabling our organizations to make this important meeting come to fruition. It was a great success.”

If you’re interested in learning more about collaboration opportunities, please contact info@hsglimited.org.

¹The body’s complement system is part of the immune system. It is responsible for defending cells and tissues from infections and diseases.

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 of over 800 experts in Huntington’s disease 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 HD-Community Advisory Board
HD-Community Advisory Board (HD-CAB) is a coalition of partners from the European Huntington Association, the International Huntington Association, and the Huntington’s Disease Youth Organization whose mission is to represent the voice of the global HD community and provide HD community experience to regulators, industry, researchers, and governing bodies. HD-CAB provides the unique expertise of living with HD to stakeholders relevant for therapeutic development. For more information, visit www.hd-cab.org.

Click here to view the full press release.

HSG Announces 30th Annual Meeting

Rochester, NY — March 21, 2023 — The Huntington Study Group (HSG), a world leader in conducting clinical trials and providing educational programming for Huntington’s disease (HD), recently announced that their 2023 Annual Meeting will be held November 2-4, 2023 at the Sheraton Grand at Wild Horse Pass in Chandler, AZ, a little south of Phoenix. This year is particularly special, as the HSG will be honoring its 30th year as an organization, along with the 30th anniversary of the HD gene discovery.

“We are proud of the work HSG has completed over the past 30 years. As Co-Chairs, we look forward to a meaningful, productive and promising future for our patients and families impacted by HD,” said Sam Frank, MD and Sandra Kostyk, MD, PhD, Co-Chairs of HSG’s Executive Membership Committee.

The three-day long Annual Meeting provides an excellent forum for scientists, industry partners, HSG research sites (largely from academic institutions), advocacy groups, members, staff, HD patients, families, and caregivers around the world to present and learn about new findings for Huntington’s disease treatments. Through the Annual Meeting, the HSG facilitates programs to provide the latest updates on current HD clinical trials, scientific advancements, and industry developments. Most importantly, the event provides opportunities for connection, networking, and collaboration. Attendees generally report leaving HSG’s annual meetings feeling energized, inspired, and full of hope and this year’s meeting should be equally impactful.

“I look forward to attending HSG’s event each year and consider it a very useful opportunity to hear from and interact with HD thought leaders, and to make valuable connections,” said Dietrich Haubenberger, MHSc, MD, Executive Medical Director for Clinical Development at Neurocrine Biosciences.

This year’s agenda is being planned by the newly formed Executive Membership Committee and the Family Day Planning Committee. Two full weekdays will be devoted to scientific updates and learning opportunities while Saturday, Family Day, will be dedicated to patients, families, caregivers, and the local HD community.

Shari Kinel, JD, CEO of Huntington Study Group noted, “We’re looking forward to everyone coming together to connect and participate in a full range of scientific programming and educational activities. We want to honor the incredible network of people who continue to support our mission of accelerating treatments that make a difference for Huntington’s disease.”

More details and registration opportunities will be coming in the next few months.
If you’d like to sponsor HSG’s 30th Annual Meeting, please click here for details.

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.
Founded in 1993 in Rochester, NY, the Huntington Study Group (HSG) is a not-for-profit organization composed of the world’s first and largest collaborative network of over 800 experts in Huntington’s disease at more than 130 HSG credentialed research sites worldwide. HSG Clinical Research, Inc., a wholly owned subsidiary of the HSG, is a full-service clinical research organization that specializes in conducting HD trials. The HSG also offers educational services for healthcare professionals and care providers on treating patients with HD. For more information, visit www.huntingtonstudygroup.org.

Click here to view the full press release.

Overnight Switch from Tetrabenazine to Deutetrabenazine Safe, Trial Shows

JAMA Neurology paper published today from ARC-HD Trial

People with Huntington disease-associated chorea can safely convert overnight from tetrabenazine to deutetrabenazine (brand name: Austedo), according to the results of the Alternatives for Reducing Chorea in Huntington Disease (ARC-HD) trial published yesterday in JAMA Neurology. The Phase III open-label, single-arm switch cohort of the trial was led by the Huntington Study Group (HSG) and the University of Rochester’s Clinical Trials Coordination Center (CTCC) on behalf of Teva Pharmaceutical Industries Ltd.

Although the topline results of the trial have been released previously, the peer-reviewed publication about the switch arm of ARC-HD clinical trial is now published in a premier neurological medical journal.

“This trial provides more good news for our patients who need options for medication to control their chorea,” 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. “We are grateful to the people who volunteered in this trial and their families who supported their participation.”

The ARC-HD trial enrolled 37 patients who were on a stable dose of tetrabenazine for 8 weeks or longer. Participants converted from tetrabenazine to deutetrabenazine at a dose that was half of their original total daily tetrabenazine dose. After one week, investigators began weekly dose adjustments, if needed, to achieve optimal chorea control. This study was focused on safety. In addition, Total Maximal Chorea Score and Total Motor Score were evaluated as efficacy endpoints.

In April, the U.S. Food and Drug Administration (FDA) approved deutetrabenazine, the second drug approved for use in the United States to treat chorea in HD. The approval was based on positive results from the First-HD study, a Phase 3 clinical trial which was also led by HSG and CTCC on behalf of Teva Pharmaceuticals. In the double-blind, placebo controlled trial, deutetrabenazine significantly decreased chorea. The results were published in JAMA, July 2016.

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.

“The deuterium chemistry can provide effective chorea control with fewer daily doses and with lower peak doses, potentially improving medication tolerance. These are both big benefits for our patients,” said Claudia Testa, MD, PhD, HSG’s co-principal investigator for ARC-HD and director of the HDSA Center of Excellence at Virginia Commonwealth University.

“It’s gratifying to see the current progress in treatments for people with Huntington disease. In addition to being grateful to the research participants who are a major driver in that progress, we are grateful to the sites and site staff whose dedication to seeking treatments that make a difference is unparalleled,” Testa added.

Much of the work that led to the completion of the ARC-HD trial was carried out by 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 ARC-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 www.ctcc.rochester.edu.

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Help4HD Blog Radio features I am the DIFFERENCE campaign

Help4HD gave the Huntington Study Group the opportunity on its radio show to update the community on our many current projects, including the I am the DIFFERENCE campaign. Katrina Hamel, VP of Help4HD, hosted the show with guests Ann Nelson, an HD community member and participant in the campaign, and Heather Hare, HSG’s director of Communications & Outreach. Listen to the show by clicking here.

To learn more about HSG 2017: Elevating HD, click here.

To participate in the HD-HI survey mentioned on the show, click here.

Updates on the HDCIP survey are forthcoming.

FDA Approves Second Drug for Huntington Disease Symptom

Frank

The U.S. Food and Drug Administration (FDA) today approved SD-809 (deutetrabenazine), the second drug approved for use in the United States to treat chorea in Huntington disease (HD), a rare, inherited neurodegenerative disorder.

The approval was based on positive results from 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. The results were published in JAMA, July 2016.

“We are so grateful to the patients and families who made this development possible by participating in this ground-breaking trial. Trial participants are the key to bringing new treatments to the entire HD community,” said Samuel Frank, MD, Huntington Study Group’s principal investigator for First-HD and associate professor of Neurology at Beth Israel Deaconess Medical Center/Harvard Medical School. Claudia Testa, MD, PhD, associate professor of Neurology at Virginia Commonwealth University served as the co-principal investigator.

Testa

“It’s exciting to offer a new treatment,” Testa said. “Trials like these give patients, families, and care providers more options to effectively manage HD symptoms and improve quality of life.”

Most individuals with HD experience chorea during the course of the disease. Huntington disease is an autosomal-dominant, inherited disease that usually manifests in people in their 30s and 40s, though some people are affected as early as childhood and others experience disease symptoms much later in life. The disease brings with it an array of symptoms besides chorea, including dystonia, cognitive problems, changes in personality, and psychiatric problems like depression. Because HD is autosomal dominant, each child of a person with HD has a 50 percent chance of inheriting the genetic change that causes the disease from their affected parent, whether that parent is their mother or father. For more information about HD, visit www.huntingtonstudygroup.org.

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. Deutetrabenazine is the first FDA approved compound with deuterium substitution. Much of the clinical work that led to the approval of deutetrabenazine was carried out by the Huntington Study Group, a non-profit network of 400 Huntington disease experts from more than 100 medical centers throughout North America, Europe, and Australia who are dedicated to seeking treatments that make a difference for people and families affected by the disease. For more information, visit www.huntingtonstudygroup.org.

“This is a great day for the HD community,” said Ray Dorsey, MD, chair of the Huntington Study Group and director of the University of Rochester’s Center for Human Experimental Therapeutics (CHET). “The unmet need for therapeutics for individuals with HD is immense, and this approval brings us closer to making HD an increasingly treatable condition.”

First-HD was conducted at 34 Huntington Study Group sites across the United States and Canada, enrolling 90 participants over 14 months, in the 13-week double-blind, placebo-controlled trial. Scientific, technical, logistical, and analytical support for the study 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 www.ctcc.rochester.edu.

Teva Pharmaceuticals owns the rights to develop and sell deutetrabenazine in the United States, following its purchase of Auspex Pharmaceuticals in 2015. 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 open-label trial is also being led by the Huntington Study Group and the Clinical Trials Coordination Center for Teva Pharmaceuticals. 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.

Media inquiries:

Huntington Study Group — +1 800-487-7671 or info@hsglimited.org

FDA Requests More Data on Potential New Treatment for Huntington Disease

Teva Pharmaceuticals Industries announced yesterday that the U.S. Food and Drug Administration (FDA) has asked for more data on SD-809 (deutetrabenazine), which is currently under review to treat Huntington disease (HD), a rare, inherited neurodegenerative disorder.

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.

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 Pharmaceutical Industries. In the double-blind, placebo controlled trial, deutetrabenazine significantly decreased chorea, the involuntary movements that many individuals with HD experience.

“We are grateful to the patients and families who have participated in First-HD and helped us get to this point. HSG will continue its role in the clinical development of this product with TEVA,” said Samuel Frank, M.D., Huntington Study Group’s principal investigator for First-HD and a movement disorders specialist at Beth Israel Deaconess Medical Center. Huntington Study Group’s co-principal investor is Claudia Testa, M.D., Ph.D., associate professor of Neurology at Virginia Commonwealth University.

Most individuals with HD experience chorea during the long course of the disease, which averages 15-20 years. Huntington disease is an autosomal-dominant, inherited disease that usually manifests in people in their 30s and 40s, though some people are affected as early as childhood and others don’t experience the diseases symptoms until much later in life. The disease is caused by the death of brain cells known as medium spiny neurons, which are killed off by a mutant protein. The disease brings with it an array of symptoms besides chorea, including cognitive problems, changes in personality, and psychiatric problems like depression. Because HD is autosomal dominant, each child of a person with HD has a 50 percent chance of inheriting the disease. For more information about HD, visit www.huntingtonstudygroup.org.

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. Much of the work that led to the completion of the First-HD trial was carried out by the Huntington Study Group, a non-profit network of 400 Huntington disease experts from more than 100 medical centers throughout North America, Europe, and Australia 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.

“While disappointed with the delay, we remain hopeful and optimistic that the FDA will soon approve the second treatment for HD,” said Ray Dorsey, M.D., chair of the Huntington Study Group and director of the University of Rochester’s Center for Human Experimental Therapeutics (CHET).

First-HD was conducted at 34 Huntington Study Group sites across the United States and Canada, enrolling 90 participants over 14 months, in the 13-week double-blind, placebo-controlled trial. Scientific, technical, logistical, and analytical support for the study 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 www.ctcc.rochester.edu.

Teva Pharmaceutical owns the rights to develop and sell deutetrabenazine in the United States, following 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 from First-HD, is also being led by the Huntington Study Group 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.

For media inquiries, contact contact HSG at +1 800-487-7671 or info@hsglimited.org.

HSG Announces Launch of CME4HD 2019 – Accredited Online Education Platform

Beginning February 1, 2019, the Huntington Study Group (HSG) will offer the latest update to its popular online learning program, CME4HD. Once again, CME4HD courses will be offered free of charge thanks in part to an educational grant from Teva Pharmaceuticals.

CME4HD originally began as in-person training on Huntington’s disease (HD) at the HSG’s annual meeting, before launching in 2018 in an online, self-paced format. Learners can earn up to 3.25 total CME, CNE or IPCE credits by completing all courses in the program. Interested learners can register for a user account on the HSG’s learning platform, and learn more about the CME4HD program on our website: https://huntingtonstudygroup.org/cme4hd-online/

The CME4HD program presents evidence driven data and examples about Huntington’s disease by stage and disease burden. CME4HD 2019 content is designed for healthcare professionals, including social workers, nurses, and neurologists, who provide care to patients with HD. Family members serving as caregivers will also find the content extremely valuable.The HSG is extremely grateful to Bridget Lyon and Jeff McDonald for allowing their documentary, The Inheritance, to be used as a case study and for these courses. The Inheritance honors the efforts of Bridget’s mother to strengthen public awareness of Huntington’s disease. She wanted people to know what it was and how it affected entire families, generation after generation. All users that register for CME4HD 2019 will have access to the full-length documentary.

CME4HD has been planned and implemented by North American Center for Continuing Medical Education, LLC (NACCME) and the Huntington Study group. NACCME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

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