The RESTORE-1, Phase 2, randomized, placebo-surgery controlled, double-blinded, multi-center clinical trial was designed to evaluate the safety and efficacy of VY-AADC for the potential treatment of advancing Parkinson’s disease.
The RESTORE-1 trial has been placed on clinical hold by the U.S. Food and Drug Administration following the submission of an IND Safety Report related to the observation of MRI abnormalities in some RESTORE-1 study participants. The trial originally paused screening, enrollment, and dosing due to the COVID-19 pandemic and as a result of the independent Data Safety Monitoring Board (DSMB)’s request to pause pending its review of patient level data.
Neurocrine has terminated the portion of the collaboration agreement related to VY-AADC for the treatment of Parkinson’s disease. The termination is effective on August 2, 2021. Voyager plans to support Neurocrine on any ongoing matters related to imaging and clinical assessments requested by the DSMB and other information requested by the FDA for the RESTORE-1 Phase 2 clinical trial.