Update on Tominersen Huntington Disease Clinical Program: Recruitment Completed
April 20, 2020
Dear Global HD Patient Community,
Today we are pleased to announce that worldwide recruitment has been completed for the Phase III GENERATION HD1 clinical trial. Following the completion of recruitment in the US that was previously announced in October 2019, a total of 791 people living with manifest HD across 18 countries have been recruited to complete global enrollment to the study. As part of our ongoing partnership and following your request to receive important and timely updates about Roche’s HD clinical programme, we wanted to share this news and update you on what happens next.
This achievement is a result of the HD community’s commitment from the beginning, and we are very grateful to all trial participants, their families, the clinical trial sites and staff, and the broader HD community who have supported the design, initiation and recruitment phases of the study.
What happens now that recruitment is complete? When will results be available?
Whilst recruitment completion is exciting news, the diligent work of trial participants and researchers is still just beginning. Each trial participant will undertake tests, medical evaluations, intrathecal injections of either the investigational therapy tominersen or placebo, and use digital monitoring tools over a twenty-five month period. Participants’ safety and trial experience will be regularly monitored by researchers at trial sites and Roche/Genentech.
After all the study participants have completed their 25-month trial period, researchers will analyse the overall study data, which we expect sometime in 2022. Should the benefit-risk profile of tominersen appear favourable, data will be submitted to health authorities for consideration as an approved treatment for people with HD.
Is the COVID-19 pandemic affecting tominersen studies?
We would like to reassure you that tominersen studies are ongoing at clinical trial sites around the world, where local guidance allows. The GENERATION HD1 trial is continuing, in collaboration with study participants, clinical trial investigators and health authorities, while also ensuring patient safety and data integrity throughout the studies given the ongoing impact of COVID-19. If trial participants have specific questions about their situation, we encourage them to discuss with their clinical trial site.
During these exceptional times, we continue to consider how we can best support the community and welcome any suggestions. For now, we wanted to thank the community again for its support and interest in the study, which has meant this important milestone could be achieved.
If you have any questions about this update, please do not hesitate to contact us.
Sincerely,
David West
Senior Director, Global Patient Partnership, Huntington Disease
Roche-Genentech
Mai-Lise Nguyen
Senior Group Director, Global Patient Partnership, Rare Diseases
Roche-Genentech
For the full PDF of this letter, click here.