Inhibitex, Inc. (Nasdaq: INHX) today reported top-line safety and efficacy data from its Phase II clinical trial of FV-100, an oral antiviral compound being developed to treat herpes zoster, more commonly referred to as shingles. The study was the first clinical trial to assess the antiviral activity of FV-100, included 350 shingles patients and compared two once-daily doses of FV-100 (200 mg and 400 mg) to an active control, valacyclovir, one of the most commonly-used antiviral drugs to treat shingles. Valacyclovir was administered three times per day at 1,000 mg per dose, or 3,000 mg daily.
“These data support the potential of FV-100 as an effective, well tolerated, once-daily therapy for the treatment of shingles.”
Numerically favorable treatment differences were observed for both doses of FV-100 compared to valacyclovir for the primary composite endpoint of the study, defined as the reduction in the severity and duration of shingles-associated acute pain over the first 30 days post-infection, or the Burden of Illness (BOI30 AUC). There were also favorable treatment differences observed for key secondary pain endpoints, including the reduction in the severity and duration of shingles-associated pain over 90 days (BOI90 AUC) and the incidence of post herpetic neuralgia, or PHN. The treatment differences observed between either of the FV-100 cohorts and the valacyclovir-treated subjects were not statistically significant. FV-100 was generally well tolerated at both dose levels, and demonstrated a similar adverse event profile as compared to valacyclovir.
"FV-100 has now demonstrated, in a well controlled trial, favorable treatment outcomes in shingles patients with the added benefit of once-daily dosing," stated Stephen Tyring, MD, PhD, a virologist at the Center for Clinical Studies in Webster, Texas and principal investigator of the Phase II trial. "These data support the potential of FV-100 as an effective, well tolerated, once-daily therapy for the treatment of shingles."
"We believe the tolerability profile and treatment advantages observed across the various pain endpoints in this proof-of-concept study confirm FV-100's potential as a standard of care therapy for the treatment of shingles," stated Russell H. Plumb, CEO and President of Inhibitex, Inc. "The treatment outcomes observed with the higher dose of FV-100 for the reduction of longer-term shingles-associated pain, and in particular, preventing PHN, are especially encouraging. Upon our review of the complete data set from the trial, we will evaluate the clinical and regulatory pathways for FV-100 and determine the next steps in its development."