Voyager Therapeutics, Inc. (VYGR), a clinical-stage biotechnology company, announced that the U.S. Food and Drug Administration or FDA has cleared the Investigational New Drug application for VY1706, the company's investigational gene therapy for Alzheimer's disease.
VY1706 has a vectorised siRNA core targeting MAPT mRNA to reduce levels of both intracellular and extracellular tau, a protein found in the brain. The preclinical program demonstrated a favourable pharmacology and safety profile for VY1706.
Based on the IND clearance, Voyager plans to initiate a multi-site, open-label, dose-escalation clinical trial of VY1706 in up to 18 adults with early AD who have evidence of tau pathology in the brain, confirmed by PET imaging. The dosing in the trial is expected to begin in the second half of the year.
The trial's primary endpoint is to evaluate the safety and tolerability of VY1706.
Secondary endpoints will assess VY1706's effect on tau biology, including changes in cerebrospinal fluid biomarkers of tau, as well as changes in tau pathology measured by tau PET imaging, the company said.
VYGR has traded between $2.83 and $5.55 over the last year. The stock closed Monday's trade at $3.79, down 2.07%.
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