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Update on Roche/Genentech GENERATION-HD1 Trial

Last week Roche/Genentech updated the HD community on their learnings from the failed GENERATION-HD1 trial. Along with the information release, they also joined two webinars – one hosted by the European Huntington’s Disease Network (EHDN) aimed toward researchers and another hosted by Huntington Disease Society of America (HDSA) for patients and families.  

Roche/Genentech is working to discover a path forward for their huntington lowering drug, tominersen, to help people with HD.  

According to Roche/Genentech, their next steps are:  

  • Tominersen program continues with plans for a new study: We are in the early stages of designing a new Phase II clinical trial. The trial intends to explore the safety and efficacy of different doses of tominersen in a younger adult patient population with less disease burden. Specifics about the study are still being determined, including enrolment criteria, planned start date, and study sites. We will share details after they are finalized, including who may be eligible to take part in the study.  
  • Current tominersen studies (GENERATION HD1, GEN-EXTEND and GEN-PEAK) will close by the middle of the year: Participant follow-up in GENERATION HD1 will continue as planned until the last participant completes their last clinic visit, which is expected in March/April 2022. The GEN-EXTEND study will also complete in March/April 2022. The GEN-PEAK study is now considered complete, because Part 1 of the study finished and the optional Part 2 will not be conducted. Closure activities at study sites will be completed by the middle of this year. We understand that study participants may have questions about how this information may impact them. Our team will continue to closely collaborate with study sites throughout the year to support participants. We encourage participants or family members to reach out to their study team for more information and next steps.”  

To learn more, check out this HD Buzz article: