Benzinga | Feb 2, 2021 04:10PM EST

Voyager Therapeutics Provided An Update On Its NBIb-1817 (VY-AADC) Gene Therapy Program

CAMBRIDGE, Mass., Feb. 02, 2021 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (NASDAQ:VYGR) today announced that Neurocrine Biosciences, Inc. (NASDAQ:NBIX) provided notice of termination of the Parkinson's disease portion of the collaboration agreement, effective August 2, 2021. The Friedreich's ataxia program and two discovery programs that are also part of the agreement are not impacted and remain under active collaboration.



Voyager's understanding is that Neurocrine's decision to terminate the NBIb-1817 (VY-AADC) program was based on a portfolio review and prioritization of its current pipeline assets. Voyager plans to support Neurocrine, the IND holder and sponsor of the RESTORE-1 Phase 2 clinical trial, on any ongoing matters related to additional imaging and clinical assessments requested by the Data Safety & Monitoring Board (DSMB) and other information that may be requested by the U.S. Food and Drug Administration (FDA).

In December 2020, Voyager announced that the FDA had notified Neurocrine that it had placed a clinical hold on the RESTORE-1 clinical trial of NBIb-1817 (VY-AADC). The FDA notification followed a request by the study's independent DSMB for a pause in dosing pending the receipt of information about magnetic resonance imaging (MRI) abnormalities observed in trial participants. In January 2021, the FDA informed Neurocrine of the information required to provide a complete response to the FDA in connection with the clinical hold. Information required by the FDA includes an assessment of how the investigational product may have given rise to the adverse findings, a mitigation plan to manage the adverse findings, and supportive data to justify that a favorable benefit/risk profile remains for the product.

Voyager is evaluating the complete financial impact of the termination and the future of the Parkinson's program and expects to provide a subsequent update.