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Today FDA has removed the clinical hold on one more gene therapy study, this time for Voyager Therapeutics Inc's (NASDAQ: VYGR) investigational new drug application for VY-HTT01, a gene therapy candidate for Huntington's disease (HD).
The agency has confirmed that the company may proceed with its planned Phase 1/2 clinical trial.
The decision comes after a comprehensive review of the Chemistry, Manufacturing, and Controls information previously submitted to the FDA.
Voyager plans to initiate VYTAL, a Phase 1/2 clinical trial of VY-HTT01, this year.
VYTAL Phase 1/2 trial is a dose-escalation study to evaluate the safety and tolerability of VY-HTT01 in patients with early manifest Huntington's disease.
Secondary endpoints include disease biomarkers and clinical outcome measures.
VY-HTT01 is a gene therapy designed to reduce the expression of huntingtin, thereby altering disease progression.
It includes adeno-associated virus capsid and a proprietary transgene that harnesses the canonical RNA interference pathway to knock down levels of HTT mRNA selectively.
Price Action: VYGR shares are moving 12.6% higher at $5.25 on the last check Monday.
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