Voyager Therapeutics (VYGR) said Monday that it expects to begin its early Alzheimer's disease trial in adults in the second half of the year after the US Food and Drug Administration approved its investigational new drug application for VY1706 in June.
The company said that toxicology data from its trial in non-human primates showed VY1706 gene therapy was well tolerated and resulted in sustained tau protein reduction of up to 75% in key brain regions following a single intravenous dose over six months.
Voyager said that VY1706 demonstrated a favorable tolerability profile in the three- and six-month good laboratory practice toxicology study, with no adverse clinical pathology or histopathological findings in the central nervous system, dorsal root ganglia, and peripheral organs up to the highest dose tested.
Shares of the company were up 3.2% in Monday's premarket activity.
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