Novartis shares disappointing update from the VIBRANT-HD trial of branaplam
This afternoon, Novartis shared with HD community organizations that dosing in the VIBRANT-HD trial of the huntingtin-lowering drug branaplam has been temporarily suspended. This decision was made based on the recommendation of an independent Data Monitoring Committee (DMC). Their review of the data showed early signs that branaplam may be causing peripheral neuropathy in some study participants.
Given that this news affects not only the early trial participants, but the wider community, HDSA would like to provide some context about the trial, share what we have learned from Novartis, and offer support to those who need it.
VIBRANT-HD was designed to test the safety of branaplam and its ability to lower huntingtin in 75 participants with early HD symptoms. The study began with a group receiving a low dose of the drug; a small group of participants received branaplam or a placebo control. Based on neurological exams, levels of a protein called NfL in blood, and other types of nerve and symptom tests, the independent DMC determined that branaplam could be causing unexpected damage to nerves outside the brain and spinal cord.
“Like all of the HD community, we are surprised and disappointed by this news about the suspension of dosing of branaplam in the VIBRANT-HD study,” said Dr. Victor Sung, HDSA Board of Trustees Chair. “We patiently await further announcements from Novartis regarding this decision and news regarding the future of branaplam for HD.”
For a deeper dive into the science behind this information, we recommend reading the HDBuzz article released on August 8th.
All of us at HDSA recognize that this news is disappointing, and that it can have an emotional toll. If you or someone you know is having difficulties processing this information, please reach out to us through the HDSA Helpline at (800) 345-4372 or click here to access any of our community and social support services and programs.