It has been announced that Roche's GENERATION HD2 study is beginning to recruit participants for their Phase II clinical trial.
This announcement comes after a long wait for the community since the disappointing news that GENERATION HD1 (which was in Phase III of the study) had to stop in March 2021. The GENERATION HD2 trial aims to evaluate the safety and efficacy of the investigational drug, tominersen.
About GENERATION HD2
The study will be recruiting from 15 countries including six possible trial sites in England - we will update you when we have more information about when these will open.
They will be enrolling 360 participants aged between 25 and 50 with very early and subtle signs of Huntington's disease.
This phase of the trial will run for at least 16 months with participants taking either torminersen (60mg or 100mg) or placebo every four months via a lumbar puncture. An independent data monitoring committee (iDMC) will be monitoring the safety of the trial at regular intervals.
A recap of what happened with GENERATION HD1
Roche stopped dosing people in the GENERATION HD2 trial because the independent data monitoring committee (iDMC) had noticed potential safety issues. In this study, participants were being dosed 120mg of torminersen every two months and every four months - a higher dose than what will be administrated in the new study.
Over the next 18 months Roche analysed the data from the trial, to try and understand what went wrong, and whether there might be a future for tominersen in Huntington's disease. New analysis showed that some participants in the trial might have benefitted from tominersen. Specifically, younger people who began the trial in earlier stages of Huntington's disease who did not seem to experience a worsening of symptoms over the course of their participation. You can read more about this here.
A message from Roche
"We sincerely thank all study participants, companions and families who supported the previous studies. These studies comprised the first-ever Phase III clinical program to test the huntingtin-lowering hypothesis. Additionally, it was because of the Huntington's community’s commitment to research that the trials recruited faster than anticipated, and thus generated data faster than anticipated. The incredible Huntington's community inspires all researchers to continue pursuing potential options for people impacted by the disease. Regardless of a study’s outcome, the journey of tominersen research is an example of how every clinical study adds to the overall body of research knowledge. Every piece of data collected is vital. Even if we learn something may not work, or may work differently than thought, together as a research community we get one step closer to finding out what may work for people with Huntington's disease. And this research can only be done with the participation of the Huntington's community."
Questions
Where can I get more information on the study?
Further study details, including inclusion and exclusion criteria, will soon be posted on ForPatients.Roche.com and clinical trial registries (e.g., ClinicalTrials.gov) as well as shared Huntington's disease specialist about what may be best for their situation. The specialist can also contact Roche/Genentech Medical Information for more information.
What is the list of countries that will be recruiting?
The GENERATION HD2 study is planned to recruit in 15 countries (Argentina, Austria, Australia, Canada, Denmark, France, Germany, Italy, New Zealand, Poland, Portugal, Spain, Switzerland, UK (just England at this moment in time) and USA). Trial sites will be made available on a progressive basis – for example, once a site’s infrastructure and approvals (from Health Authorities and Ethics Committees/IRBs) are in place, and sites are nearly ready to enrol patients.
For any clinical study, it is possible that for various reasons an expected study site/country does not proceed to enroll participants. Alternatively, additional locations may be added.
Will previous tominersen study participants be able to participate in the new study?
Phase III GENERATION HD1 study participants who received placebo and who meet the new Phase II GENERATION HD2 study eligibility criteria may potentially enroll in the upcoming tominersen study. However, clinical trial site locations are still being confirmed. The GENERATION HD2 study is testing tominersen in previously untreated adults, therefore individuals who previously received tominersen will not be eligible for the study. This decision was made following extensive consultation with Huntington's experts and community leaders, though we recognise that this may still be disappointing news for some individuals.