Neurocrine Biosciences’, Voyager Therapeutics’ Mid-Stage Gene Therapy Trial Stopped
The FDA has placed a clinical hold on a phase 2 trial of Neurocrine Biosciences’ and Voyager Therapeutics’ investigational Parkinson’s disease gene therapy, citing a potential safety issue.
The trial, which is being run by Neurocrine with help from Voyager, was placed on hold after Neurocrine submitted a safety report related to magnetic resonance imaging (MRI) abnormalities in some participants. The companies are co-developing the investigational gene therapy, which they hope can restore motor function in Parkinson’s patients and improve symptoms following a single administration.
“The clinical implications of this observation are currently unknown and are being evaluated,” Voyager said. “Neurocrine Biosciences and Voyager will work closely with the FDA and the [data and safety monitoring board] to determine the next steps for the … clinical trial.”