In the preclinical toxicology studies, the compound was generally safe and well tolerated in animals at dose levels that are expected to exceed a therapeutically relevant dose. In addition, preclinical pharmacokinetic studies indicated that single oral doses of FV-100 can produce prolonged plasma concentrations over twenty-four hours, suggesting the potential for a once-a-day dosing regimen, the company said.
Geoffrey Henson, CEO of FermaVir, said: “Importantly, the data reinforces our belief that FV-100 has the potential to be a more potent treatment option for shingles with the advantage of a favorable safety profile and once-a-day dosing regimen as compared to currently-available therapies, and provides a path forward for filing an investigational new drug application in the near future and commencing the clinical development of FV-100.”
In the preclinical studies, FV-100 was administered as a single oral dose at 100mg, 500mg, or 2,000mg/kg in both rats and dogs. Following a 14-day observation period, toxicity data from both species revealed no mortalities or significant adverse events. Additionally, genotoxicity and phototoxicity studies were also negative.