Novartis has temporarily suspended dosing of study drug in the Ph2b VIBRANT-HD trial of branaplam in adults with Huntington’s Disease. This decision was based on a recommendation from the independent Data Monitoring Committee (DMC) following a planned data review and was endorsed by the VIBRANT-HD steering committee. We have subsequently communicated with study investigators and HD community and remain committed to sharing timely updates as soon as we are able to.
This decision is based on several findings suggestive of potential peripheral neuropathy in some participants. The DMC did not recommend terminating the study at this time. Treatment with study drug is being temporarily suspended and participants will continue to have regular study assessments per the protocol.
We understand the devastating impact of HD on people living with the disease and their families, and will continue to work closely with those involved in the study and thoroughly assess all available information, including data to be collected in the coming weeks, to better understand these findings and inform next steps for the program.