Inhibitex reports positive results from shingles trial

The blinded, placebo-controlled single ascending dose study, which was conducted in the US under an exploratory investigational new drug application, evaluated the safety and pharmacokinetics of three oral doses of FV-100 (10, 20 and 40mg) in healthy volunteers. Each of the three dose cohorts consisted of six subjects that received FV-100 and two that received placebo.

The company reported that there were no serious adverse events observed and that the compound appeared to be generally well tolerated in the trial. In addition, pharmacokinetic data demonstrated that all three doses achieved plasma levels of CF-1743, the active form of FV-100, which exceeded the EC50, with the 40mg dose maintaining such levels for approximately eight hours. The EC50 represents the concentration of drug that is required for 50% inhibition of viral replication in vitro. Further, the plasma levels of CF-1743 in humans were greater than those observed in preclinical studies. The company plans to present the full data from this trial at a scientific meeting next year.

Russell Plumb, president and CEO of Inhibitex, said: “Based upon these results, and pending the results from our ongoing multi-dose preclinical GLP studies, we plan to advance FV-100 into a second Phase I trial evaluating FV-100 in additional single ascending and multiple ascending doses in healthy volunteers in the first half of 2008.”