Press Releases

Huntington Study Group Announces A Partnership with Prilenia Therapeutics to Conduct A Global Phase 3 Clinical Study of Pridopidine in Huntington’s Disease

Rochester, N.Y.  — September 17, 2020 —The Huntington Study Group (“HSG”), a world leader in clinical research for Huntington’s Disease (HD), announces a partnership with Prilenia Therapeutics, a clinical stage biotech company led by Michael R. Hayden, MD, PhD, to conduct PRidopidine Outcome On Function in Huntington’s Disease (PROOF-HD) clinical study.  PROOF-HD is a global Phase 3, randomized, double-blind, placebo-controlled, parallel arm, multicenter study evaluating the efficacy and safety of pridopidine in patients with early stage HD.

Pridopidine is a first in class small molecule which  is a highly selective Sigma-1 receptor (S1R) agonist. Prior trials of pridopidine in HD have demonstrated good safety and tolerability. The PROOF-HD study seeks to demonstrate that pridopidine slows functional decline over 65 weeks of treatment.

In a prior Phase 2 clinical study, PRIDE-HD, pridopidine administered orally twice a day, was associated with maintenance of functional capacity from baseline compared to placebo at 52 weeks in patients with early HD, as measured by Total Functional Capacity (TFC). Extensive safety data from over 1300 subjects exposed to various oral daily doses of pridopidine demonstrates pridopidine has a favorable safety profile and is well tolerated.

“Slowing the decline in functional capacity in HD patients would be a significant advance in HD care,” said Andrew Feigin, MD, North American Principal Investigator of PROOF-HD. “We are excited to partner with Prilenia to study pridopidine – this study directly aligns with HSG’s mission of seeking treatments that make a difference for those affected by  HD.”

HSG is also partnering with TFS International AB, a clinical research organization (CRO), to conduct this trial in Europe, and with the Clinical Trials Coordination Center at the University of Rochester to assist with efforts in North America.  PROOF-HD will be conducted through HSG Clinical Research, Inc.  

“This is an exciting time in Huntington’s Disease research,” added Ralf Reilmann, MD, PhD, the European Principal Investigator of the study. “Prior trials of pridopidine have suggested that it may maintain functional capacity in early HD patients, as measured by Total Functional Capacity (TFC). PROOF-HD will focus on this potential effect.”

The PROOF-HD study plans to enroll 480 participants aged 25 or older with a clinical diagnosis of adult-onset HD in approximately 30 study centers across the U.S. and Canada, and another 30 study centers across Europe. The study will include a screening period, a double-blind placebo-controlled treatment period up to 78 weeks and optional open-label extension. “There is extensive preclinical evidence that further supports pridopidine’s potential beneficial effect in HD,” said Michael R. Hayden, MD, PhD, Chief Executive Officer at Prilenia. “It is a first-in-class drug candidate, with promising previous clinical results and an established safety profile. We are pleased to be partnering with HSG to explore its impact through the PROOF-HD study.”

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. Additional characteristics of HD include weight loss (probably from a combination of difficulty eating, and calories burned by the involuntary movements), difficulty swallowing, and hard-to-understand speech. About 30,000 people in North America have HD, and another 150,000 are considered “at risk” for inheriting the illness because they have (or had) a parent with HD.

About 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. HSG Clinical Research, Inc. is a wholly-owned for-profit subsidiary of the HSG, conducts clinical trials to benefit the HSG and its mission of seeking treatments that make a difference for those affected by HD. There are 700 credentialed HD experts at more than 120 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.

About Prilenia

Prilenia is a clinical stage biotech startup founded in 2018 with the purpose of improving the lives of patients and their families by developing treatments for neurodegenerative and neurodevelopmental disorders. Prilenia raised $ 82.5 million thus far and is backed by a group of well-respected investors: Talisman, Forbion, Morningside and Sectoral. The Company is based in Naarden, the Netherlands, Herzliya, Israel and Boston, MA in the U.S. For more information about Prilenia and Pridopidine, please email info@prilenia and visit Prilenia’s website: www.prilenia.com.

About TFS International

TFS was founded in 1996 and has grown to become the leading global mid-size clinical CRO focusing on small and mid-size Biotech customers. TFS employs nearly 700 professionals throughout 21 countries and currently delivers clinical research services in more than 40 countries. TFS provides end-to-end solutions including full clinical development services, strategic resourcing, and flexible single services. TFS partnering approach with customers is based on our four business principles – commitment, flexibility, value creation and global reach. Our core therapeutic specialties are Dermatology, Hematology and Oncology, Ophthalmology as well as Internal Medicine and Neurology. Detailed information about TFS, and its business offerings can be obtained through www.tfscro.com.

About the CTCC

The Clinical Trials Coordination Center (CTCC) is part of the University of Rochester Medical Center’s Center for Health + Technology (CHeT). The CTCC specializes in the development, management, and conduct of clinical research studies. Over the past 25 years, the CTCC has managed the conduct of over 100 clinical research studies with 45 sponsors (government, industry, and private) that enrolled over 38,000 research participants in US, Canada, Europe, New Zealand, and Australia. Visit the CTCC website https://www.urmc.rochester.edu/health-technology/our-expertise/clinical-trials-coordination.aspx.

Huntington Study Group Launches New CME Accredited Interactive Case Study Courses

The Huntington Study Group (HSG), a world leader in spearheading research and conducting clinical trials in Huntington disease (HD), has launched a new offering to its acclaimed CME4HDTM online learning curriculum. The 2020 edition of CME4HDTM features seven interactive case studies that build upon the faculty lecture content launched last year (2019). Learners are presented with real world scenarios that healthcare professionals may encounter working with patients or families at various stages of Huntington disease, and answer questions to determine the best course of action for the scenario. 

“The vision of CME4HD is to show healthcare professionals and providers a way to care for HD patients and families using currently available interventions,” said Dr. Mary Edmondson, Chair of the HSG Provider Education Committee. “Through this program, we hope to inspire them to learn more about this fascinating and challenging patient population and their remarkable families, and to “spotlight” clinical problems that, if managed well, have a great impact in terms of the quality of life for patients and a lasting effect within the extended family.”

Learners can earn up to 1.75 total credits at no cost (CME, CNE, or IPCE). Users with existing HSG Litmos accounts can login and take the new courses at their leisure. New users can sign up for a complimentary HSG Litmos learning account by following the steps on the HSG website (https://huntingtonstudygroup.org/cme4hd-online/). This activity has been supported through an independent educational grant from Genentech. 

“The Huntington Study Group has long been seen as a leader in education on Huntington disease for healthcare professionals. We are proud to continue offering a high quality program like CME4HD to the provider community,” said Dr. Andrew Feigin, HSG Chair. “The efforts of Dr. Edmondson and the Provider Education Committee are reflective of the passion we all have to improve the quality of care for HD patients and families.”

About HSG

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 disease. The mission of the HSG is seeking treatments that make a difference for those affected by HD. With more than 700 credentialed HD experts at over 125 HSG credentialed research sites worldwide, the HSG is a leader in conducting clinical trials for HD. The HSG also offers educational services like CME4HD ™ for healthcare professionals and care providers on treating patients with HD. For more information, visit our website www.huntingtonstudygroup.org.

About CME4HDTM

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.

HSG Announces Virtual Annual Meeting in 2020

The Huntington Study Group announced that it is taking the early and proactive step of moving this year’s annual meeting, HSG 2020: HD IN FOCUS, to a virtual experience during October 29-31, 2020. “While we will not gather together this year in-person, we have developed an interesting, novel, and innovative program that will be brought to you anywhere you are located,” said Huntington Study Group Chair Andrew Feigin, MD in an email to HSG members and the HD community.

The Huntington Study Group will hold a highly engaging and interactive virtual online meeting. HSG 2020 will still provide many of the same experiences attendees are used to — but from the safety and comfort of their home or office, which includes opportunities to network and interactive poster sessions, and much more, such as:

  • INTERACTIVE SESSIONS – plenary presentations, panel discussions, with live Q&A sessions sharing the latest in research and treatments.
  • An exciting VIRTUAL FAMILY DAY symposium for HD families to hear from HD experts and community advocates.
  • BREAKOUT SESSIONS and WORKING GROUPS.
  • CONTINUING EDUCATION (CE) credits for attending sessions.
  • Virtual NETWORKING LOUNGES to meet up with, engage and collaborate with colleagues, friends, and experts.
  • A simulated EXHIBIT HALL to engage with representatives from industry and advocacy.
  • An interactive POSTER PAVILION to browse accepted research abstract posters, and engage with poster presenters at scheduled times.

Additional details, registration information, and call for abstracts will be made available in the coming weeks. You can also bookmark our HSG 2020 web page for the latest upddates (https://huntingtonstudygroup.org/hsg-2020).

Huntington Study Group will be updating sponsor packages with some exciting opportunities to maintain a consistent experience as our usual in-person event. Organizations interested in sponsorship or exhibitor opportunities are requested to contact Kristin Strazdins (kristin@hsglimited.org or 585.242.0967) for more information on becoming a sponsor and/or exhibitor.

Publication of Clinical Guidelines for Physical Therapy in Huntington Disease

For Immediate Release: February 27, 2020

The Huntington Study Group (HSG), a world leader in spearheading research and conducting clinical trials in Huntington disease (HD), is excited to announce that the final Clinical Guidelines for Physical Therapy in Huntington’s Disease, and the final report for the Guidelines Development Group have been published in the journal Neurology.

“Until we find a cure for Huntington’s disease, the primary goal is to optimize function and quality of life for our patients,” said Dr. Martha Nance, Chair of the HSG Family Education Committee and Director of the HDSA Center of Excellence at Hennepin County Medical Center. “These guidelines promote evidence-based care for the patients of today—by HD specialists and non-specialists alike—while at the same time identifying topics for future research.”

The study, funded by the Huntington Study Group, European Huntington Disease Network, and the Griffin Foundation, provides recommendations for specific physical therapy interventions for people with HD. The study concluded that there is strong evidence to support aerobic exercise, alone or in combination with resistance training to improve fitness and motor function, and supervised gait training to improve gait in persons with HD. “The Huntington Study Group is proud to support the research that resulted in the publication of physical therapy guidelines for individuals with HD,” said Dr. Andrew Feigin, HSG Chair. “The result of research efforts such as this serve to reaffirm the overall mission of the HSG, which is seeking treatments that make a difference for those affected by this rare disease.”

About the Huntington Study Group

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 disease. The mission of the HSG is seeking treatments that make a difference for those affected by HD. With more than 650 credentialed HD experts at over 125 HSG credentialed research sites worldwide, the HSG is a leader in conducting clinical trials for HD. The HSG also offers educational services like CME4HD ™ for healthcare professionals and care providers on treating patients with HD. For more information, visit our website www.huntingtonstudygroup.org.

Huntington Study Group Announces Initiation of Phase III Clinical Study of Valbenazine for the Treatment of Chorea Associated with Huntington Disease

For Immediate Release: November 14, 2019

The Huntington Study Group (HSG), a world leader in spearheading research and conducting clinical trials in Huntington disease (HD), today announced the initiation of KINECT-HD, a Phase III clinical study of valbenazine, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, for the treatment of chorea associated with HD. Chorea, one of the most common symptoms of HD, refers to involuntary twitching movements that first tend to involve the fingers and toes and then progress to include the whole body. KINECT-HD is a multi-center, randomized, double-blind, placebo-controlled study conducted in collaboration with the University of Rochester’s Clinical Trials Coordination Center, and sponsored by Neurocrine Biosciences, a neuroscience-focused biopharmaceutical company that discovered and developed valbenazine. Valbenazine is approved by the FDA to treat adults with tardive dyskinesia, an involuntary movement disorder characterized by movements in the face, tongue, or other body parts.

Chorea is one of the most common and disruptive symptoms of Huntington disease that affects every aspect of a patient’s life and daily function,” said Erin E. Furr Stimming, M.D., principal investigator of the KINECT-HD study for the HSG, and associate professor of neurology at McGovern Medical School, UTHealth in Houston. “We’re excited to partner with Neurocrine Biosciences to explore valbenazine as a potential treatment for chorea associated with Huntington disease, and further the Huntington Study Group’s mission to find more effective treatments for people living with this devastating disorder.”

The KINECT-HD study is currently enrolling participants aged 18 to 75 with a clinical diagnosis of HD with chorea at 55 study centers across the U.S. and Canada. The 18-week study will include a screening period, a treatment period, and a follow-up period.

“As part of our continued commitment to advancing life-changing treatments for people with movement disorders, we’re pleased to partner with the Huntington Study Group to evaluate valbenazine as a potential therapy to address chorea associated with Huntington disease,” said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. “Valbenazine is currently FDA-approved for the treatment of tardive dyskinesia, an irreversible involuntary movement disorder, and we hope to show similar benefits in addressing the motor symptoms associated with chorea in patients with Huntington disease.”

About Huntington Disease

Huntington disease (HD) is a hereditary neurodegenerative disease characterized by a movement disorder, psychiatric difficulties, and cognitive changes, usually beginning in middle adult life. Additional characteristics of HD include weight loss (probably from a combination of difficulty eating, and calories burned by the involuntary movements), difficulty swallowing, and hard-to-understand speech. About 30,000 people in North America have HD, and another 150,000 are considered “at risk” for inheriting the illness because they have (or had) a parent with HD.

About HSG

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 disease. The mission of the HSG is seeking treatments that make a difference for those affected by HD. With over 700 credentialed HD experts at more than 120 HSG credentialed research sites worldwide, the HSG is a leader in conducting clinical trials for HD. The HSG also offers educational services like CME4HD ™ for healthcare professionals and care providers on treating patients with HD.

Huntington Study Group Spotlighted on Rochester, NY Television

For Immediate Release: April 12, 2019

The Huntington Study Group (HSG) was recently featured on morning programming at two local news stations in Rochester, NY. WROC News Channel 8 (CBS affiliate) and Fox Rochester (WUHF) scheduled appearances by the HSG following the recent announcement of their 100th credentialed research site in North America. The interviews highlight the Huntington Study Group’s role in conducting HD clinical trials, raising awareness of the disease to the community, and providing professional education to healthcare professionals.

Links to the recorded interviews are included below.

April 10, 2019 (WROC) – http://bit.ly/HSG_WROC_Apr2019

April 11, 2019 (Fox Rochester) – http://bit.ly/HSG_GDroc

About HSG

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 disease. The mission of the HSG is seeking treatments that make a difference for those affected by HD. With more than 650 credentialed HD experts at 122 HSG credentialed research sites worldwide, the HSG is a leader in conducting clinical trials for HD. The HSG also offers educational services like CME4HD ™ for healthcare professionals and care providers on treating patients with HD. For more information, visit our website www.huntingtonstudygroup.org.

Media Note: High-resolution photos and bios of HSG leaders are available upon request. Photo/footage opportunities may also be arranged.

Huntington Study Group Achieves 100th Credentialed Research Site Milestone

For Immediate Release: March 25, 2019

The Huntington Study Group (HSG), a world leader in spearheading research and conducting clinical trials in Huntington disease (HD), is excited to announce that it has credentialed Inland Northwest Research, LLC as the 100th HSG site in North America.
“On behalf of myself and our site I wish to thank the committee for their consideration and review,” said Dr. Jason Aldred, of Inland Northwest Research. “We very much look forward to working with HSG on behalf of patients and families living with HD.”
In addition to the 100 HSG credentialed sites in the United States and Canada, the HSG has another 22 credentialed research sites worldwide. To receive HSG credentialed status, a research site must be involved with the care of individuals with HD, have a demonstrated history of conducting HD trials or research studies, maintain staff who are experienced in HD, and include an HSG-credentialed investigator and coordinator.
“The landscape of Huntington disease continues to evolve at a rapid pace, with many new potential treatments at or coming to clinical trials” said Dr. Andrew Feigin, HSG Chair. “The Huntington Study group is pleased to welcome Inland Northwest Research as our 100th credentialed site in North America. The depth and breadth of coverage that our sites provide to the HD community is evidence of the HSG’s commitment to growing to meet the needs for HD clinical research, while positioning the HSG to help support future widespread delivery of these novel therapies.”

About HSG

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 disease. The mission of the HSG is seeking treatments that make a difference for those affected by HD. With more than 650 credentialed HD experts at 122 HSG credentialed research sites worldwide, the HSG is a leader in conducting clinical trials for HD. The HSG also offers educational services like CME4HD ™ for healthcare professionals and care providers on treating patients with HD. For more information, visit our website www.huntingtonstudygroup.org.

Media Note: High-resolution photos and bios of HSG leaders are available upon request. Photo/footage opportunities may also be arranged.

The Huntington Study Group Announces New Education Committees

Rochester, NY – March 11, 2019

Today the Huntington Study Group (HSG) announced the restructuring of its Education Committee into four distinct committees aligned with the organization’s overall strategic plan for educational programs. The four committees that will lead the HSG’s current and planned education initiatives are: Member Education, Provider Education, Family Education, and Annual Meeting Education.

The HSG has selected several longstanding members of the organization that are well-known experts in their field for an initial 3-year term. Dr. Mary Edmondson has agreed to chair the Provider Education Committee. Jody Goldstein will chair the Member Education Committee. Dr. Martha Nance will serve as chair for the Family Education Committee, while Dr. Lauren Seeberger will take on the role of chair for the Annual Meeting Education Committee.

“The Huntington Study Group is very fortunate to have so many dedicated professionals working on Huntington’s disease as members of HSG – like Dr. Edmondson, Dr. Nance, Dr. Seeberger, and Ms. Goldstein,” said Dr. Andrew Feigin, HSG Chair. “We believe that working collaboratively, but in more focused teams will help enhance the quality of our educational offerings, and move the HSG educational agenda forward.”

About HSG
Founded in 1993, the Huntington Study Group is a not-for-profit company and the world’s first Huntington’s Disease (HD) cooperative therapeutic research organization. The HSG is a leader in conducting clinical trials for HD. The HSG also offers educational services to healthcare professionals and care providers on treating patients with HD.

For More information:
Kevin Gregory
585-244-8804
kevin.gregory@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.

HSG Announces Location for 2019 Annual Meeting

The Huntington Study Group announces Sacramento, California as the location for this year’s annual meeting: HSG 2019. Dr. Vicki Wheelock and her team at our UC Davis site will serve as the HSG Host Site for what has long been the organization’s hallmark event, bringing together leaders in HD research, the HD community, sponsors, and families to share their knowledge.

HSG 2019 general sessions will be held on November 7th and 8th, with the event concluding on Saturday, November 9th at the Hyatt Regency. This year’s meeting will continue to feature the signature Family Day session on Saturday for families members to get in-person insights and helpful advice for leaders in the field. Saturday will also offer the HSG’s accredited provider training, CME4HD, in-person.

Additional information regarding registration and agenda will be provided as those details become available.

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