Fermavir shingles drug shows potential in animal trials

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.