With Sandoz Spinoff, Novartis Slams Brakes On Huntington's Trial

Novartis AG NVS suspended dosing in a Huntington's disease study because early signs of side effects were seen in some participants in the trial.
The pharma giant wrote in a letter shared with the Huntington's Disease Society of America that there are concerns that "branaplam might be causing peripheral neuropathy, which results from injury to the nerves located outside of the brain and spinal cord."
The trial's independent data monitoring committee recommended the suspension after a planned review unearthed findings that suggested possible side effects.
According to Novartis, early signs of side effects were observed in some participants, though the number of patients experiencing this side effect was not disclosed.
Also Read: Novartis To Spinoff Sandoz Business To Create #1 European Generics Company.
The phase 2b trial, dubbed VIBRANT-HD, is a placebo-controlled study aimed to recruit 75 patients. The trial was slated to complete in 2025.
In the letter to HDSA, the company wrote that it specifically designed the trial with "robust monitoring" so that early safety signals could be caught.
Novartis will still move ahead with planned assessments of existing VIBRANT-HD data. The company will continue to gather more information over the next few months to determine the next steps.
Branaplam is an orally administered mRNA splicing modulator with an FDA fast-track designation in Huntington's.
Price Action: NVS shares are down 1.03% at $82.75 on the last check Thursday.