Inhibitex reported top-line safety and efficacy data from its Phase 2 clinical trial of FV-100 for the treatment of herpes zoster, more commonly referred to as shingles. The study included 350 shingles patients and compared two once-daily doses of FV-100 (200mg and 400mg) to an active control, valacyclovir. Valacyclovir was administered 3 times per day at 1000mg per dose, or 3000mg daily. 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).
Shingles patients who received 200 mg or 400 mg FV-100 experienced 3% and 7%, respectively, relative treatment differences compared to patients treated with valacyclovir as measured by the primary endpoint. In addition, patients treated with 200 mg and 400 mg FV-100 experienced a respective 4% and 14% reduction in the burden of shingles-associated pain over the first 90 days compared to those treated with valacyclovir. Further, 18% and 12% of the patients receiving 200 mg and 400 mg FV-100, respectively, developed PHN, compared to 20% of the valacyclovir-treated patients, resulting in relative treatment differences of 12% and 39%, respectively. In patients receiving valacyclovir, the time to lesion crusting was faster than those patients receiving FV-100. However, no differences were noted between the treatment arms on time to full lesion healing.
FV-100 is an orally-available bicyclic nucleoside analogue that inhibits replication of varicella zoster virus (VZV).
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