Voyager Therapeutics (Nasdaq: VYGR) shares dropped -14.73% to $7.7 in the After-market session on Tuesday after the U.S. Neurocrine Biosciences (Nasdaq: NBIX) has been told by the Food and Drug Administration (FDA) that it has put a clinical hold on the NBIb-1817b clinical trial RESTORE-1 (VY-AADC). It was previously disclosed that sites participating in RESTORE-1 had not been screening, enrolling, or dosing patients due to the ongoing COVID-19 pandemic and more recently, the independent Data Safety Monitoring Board’s request to pause the study in order to collect additional data. The DSMB sought further patient level data from the study and is now preparing to revisit this data at the beginning of 2021. The clinical retention follows the submission of an IND Safety Report by Neurocrine Biosciences pertaining to the observation of MRI anomalies in certain members of the RESTORE-1 trial. At present, the clinical effects of this finding are uncertain and are being assessed.
RESTORE-1 is a phase 2 clinical trial of the intracerebral AAV-based investigational gene therapy NBIb-1817 (VY-AADC) in progress for Parkinson’s disease treatment. As well as the research investigators and national and local ethics boards, the RESTORE-1 DSMB was told of the therapeutic keeping. In order to define the next steps for the RESTORE-1 clinical trial, Neurocrine Biosciences and Voyager will collaborate closely with the FDA and the DSMB.