We would like to share an important update from Aardvark Therapeutics.
Aardvark has announced a voluntary pause of the Phase 3 HERO clinical trial, which is evaluating ARD‑101 for the treatment of hyperphagia in people with Prader‑Willi syndrome. The decision to pause the trial is based on reversible cardiac observations identified in a non-PWS, separate healthy volunteer study at higher‑than‑target therapeutic doses during routine safety monitoring. Aardvark is conducting a comprehensive review of the data to help determine next steps. Out of an abundance of caution, the company has paused ongoing enrollment and dosing in the HERO trial while this evaluation is underway.
We understand that news like this can feel disappointing and unsettling. Clinical research is complex, and while pauses are difficult, they are sometimes necessary to ensure studies proceed safely, thoughtfully, and responsibly.
If you or your family member is participating in the HERO trial, please continue to direct any immediate questions to your clinical trial site. We expect to share details soon about a community conversation next week, which will provide space for questions, share what we currently know, and discuss what this update means for the PWS community. Please stay tuned for additional information.
We will continue to keep you informed as more information becomes available.
For additional details, you can read the full announcement at the button below.
Perry A. Zirkel has written more than 1,500 publications on various aspects of school law, with an emphasis on legal issues in special education. He writes a regular column for NAESP’s Principal magazine and NASP’s Communiqué newsletter, and he did so previously for Phi Delta Kappan and Teaching Exceptional Children.
Jennifer Bolander has been serving as a Special Education Specialist for PWSA (USA) since October of 2015. She is a graduate of John Carroll University and lives in Ohio with her husband Brad and daughters Kate (17), and Sophia (13) who was born with PWS.
Dr. Amy McTighe is the PWS Program Manager and Inpatient Teacher at the Center for Prader-Willi Syndrome at the Children’s Institute of Pittsburgh. She graduated from Duquesne University receiving her Bachelor’s and Master’s degree in Education with a focus on elementary education, special education, and language arts.
Evan has worked with the Prader-Willi Syndrome Association (USA) since 2007 primarily as a Crisis Intervention and Family Support Counselor. Evans works with parents and schools to foster strong collaborative relationships and appropriate educational environments for students with PWS.
Staci Zimmerman works for Prader-Willi Syndrome Association of Colorado as an Individualized Education Program (IEP) consultant. Staci collaborates with the PWS multi-disciplinary clinic at the Children’s Hospital in Denver supporting families and school districts around the United States with their child’s Individual Educational Plan.
Founded in 2001, SDLC is a non-profit legal services organization dedicated to protecting and advancing the legal rights of people with disabilities throughout the South. It partners with the Southern Poverty Law Center, Protection and Advocacy (P&A) programs, Legal Services Corporations (LSC) and disability organizations on major, systemic disability rights issues involving the Individuals with Disabilities Education Act (IDEA), Americans with Disabilities Act (ADA), and the federal Medicaid Act. Recently in November 2014, Jim retired.