Suspending is not Ending: Updates about the Novartis VIBRANT-HD trial
– Written by the Moving Forward team on September 8th 2022
At the end of August, Novartis has written a letter to the HD community to explain the reasons behind their decision to temporarily suspend dosing of Branaplam in the Phase 2b VIBRANT-HD study with adults with HD. Novartis stated that:
“ This decision was made because early signs of side effects were seen in some participants in the trial. The recommendation was made by an independent Data Monitoring Committee, following a regularly planned data review, which revealed findings that suggested possible side effects – specifically that branaplam might be causing peripheral neuropathy, which results from injury to the nerves located outside of the brain and spinal cord. The VIBRANT-HD steering committee, made up of medical professionals and community members, endorsed the decision to temporarily suspend dosing. We would like to emphasize that the study is moving forward with planned assessments. The study was specifically designed with robust monitoring to detect early safety signals and to allow us to make informed decisions for the trial. We will be gathering more data and information in the coming months to better understand these effects and decide on next steps. “
Novartis also said that “We understand the devastating impact of HD on people living with the disease and their families. We will continue to work closely with those involved in the study and thoroughly assess all available information, including data to be generated in the coming months, to better understand these findings and inform next steps for the trial. We also remain committed to working with patient community leaders and will share timely updates with you and others in the HD community as soon as we are able to in the months ahead. “
While we know that this kind of news always comes as a shock to all families living with HD, we must remember that we are protecting and safeguarding the health of the brave and generous patients who have voluntarily signed up for this research. Also, as time is money, the sooner we can detect if something is wrong, the sooner we can redirect our efforts to find out what the problems are, analyze them, and look for solutions to reach an effective treatment for HD as soon as possible.
We’re sure that the entire Novartis scientific team will work hard to find out exactly what this situation entails, and that this knowledge will prove invaluable to the global HD community. In the meantime, we remain hopeful and grateful for all the work that is being done and for the crucial role of the persons who participate in these trials to bring us closer to a treatment that can halt HD.
The Moving Forward team will keep the community updated about this and other important research news, and will continue to provide as many resources as possible to help people better cope with HD.
More details about the Novartis trial can be found here:
