FDA clinical hold on Neurocrine/Voyager Parkinson's gene therapy trial

 

• Neurocrine Biosciences (NASDAQ:NBIX) and collaboration partner Voyager Therapeutics (NASDAQ:VYGR) have announced that the FDA has put a clinical hold on RESTORE-1 trial evaluating NBIb-1817 (VY-AADC) in Parkinson's disease.
• The independent Data Safety Monitoring Board has requested additional patient level data from the trial, which it plans to review in early 2021.
• The hold follows the submission by Neurocrine Biosciences of an IND safety report related to the observation of MRI abnormalities in some RESTORE-1 study participants. Clinical implications of this observation are unknown and are being evaluated.
• Both the companies will work closely with the FDA and the DSMB to determine the next steps for the RESTORE-1 clinical trial.
• As previously announced, Voyager, Neurocrine paused patient screening, enrolling or dosing in RESTORE-1 trial, as a result of the COVID-19 pandemic.
• NBIb-1817 is an investigational gene therapy product designed to deliver the AADC gene directly in brain cells where it can convert levodopa to dopamine.
• https://seekingalpha.com/news/3646832-fda-puts-clinical-hold-on-neurocrine-voyagers-parkinsons-gene-therapy-trial