Business
Voyager Therapeutics Announces Fourth Quarter and Full Year 2019 Financial Results and Corporate Updates
Protocol amendment being implemented for ongoing RESTORE-1 trial of VY-AADC (NBIb-1817) for Parkinson’s disease; plan to initiate RESTORE-2 trial in 2H 2020
About this update from Voyager Therapeutics, Inc.
[{"type":"text","content":"Protocol amendment being implemented for ongoing RESTORE-1 trial of VY-AADC (NBIb-1817) for Parkinson’s disease; plan to initiate RESTORE-2 trial in 2H 2020\n Update on VY-HTT01 for Huntington’s disease preclinical program expected in 2Q 2020 Strong financial position with ~$282M of cash at the end of 2019 and expected runway into mid-2022 CAMBRIDGE, Mass., March 03, 2020 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (NASDAQ: VYGR), a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases, today reported its fourth quarter and full year 2019 financial results, program progress and corporate updates. “In 2019, we took important steps toward our vision of establishing Voyager as the leader in neurological gene therapy, including forming our strategic collaboration with Neurocrine Biosciences, expanding our partnership with AbbVie, and further progressing our wholly-owned and partnered programs,” said Andre Turenne, President and CEO of Voyager. “Turning to 2020, we are excited to continue this momentum across all programs. These initiatives include presenting longer-term data from the Parkinson’s disease program, advancing our Huntington’s disease program, and further leveraging our novel capsid research and expertise in vector engineering and delivery toward additional pipeline programs.” Recent Corporate Highlights and Program Outlook VY-AADC for Parkinson’s Disease Based upon FDA feedback, the protocol of the RESTORE-1 clinical trial of VY-AADC is being amended to enroll approximately 85 patients, randomized 2:1 to receive either VY-AADC treatment or a sham surgical procedure (compared to 1:1 prior randomization). There are no changes to the primary or key secondary endpoints, but certain exploratory endpoints are being eliminated from this registrational trial. Neurocrine Biosciences and Voyager expect to update trial enrollment timelines following implementation of the protocol amendment at the trial sites.Neurocrine Biosciences and Voyager plan to initiate the global RESTORE-2 trial in the second half of 2020.VY-AADC is also being evaluated in an ongoing Phase 1 development program designed to establish safety and optimize dosing and delivery. Neurocrine Biosciences and Voyager expect to present final three-year data on all three cohorts (15 total patients) of the...