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Inhibitex reported results from a phase II trial of FV-100 for the treatment of shingles. This controlled, double-blind study enrolled 350 subjects, aged 50 years and older, across several US sites. The subjects were equally randomized to one of three treatment arms: 200 mg or 400 mg FV-100 administered once daily or 1,000 mg valacyclovir (standard of care) administered three times per day. Both doses of FV-100 showed improvement over valacyclovir in the primary endpoint, the reduction in the severity and duration of shingles-associated acute pain over the first 30 days post-infection (3% and 7%, difference). The the 200 mg and 400 mg FV-100 arms also resulted in a respective 4% and 14% reduction in the burden of shingles-associated pain over the first 90 days compared to the valacyclovir arm. In addition, 18% and 12% of subjects receiving 200 mg and 400 mg FV-100, respectively, developed PHN, compared to 20% of the valacyclovir-treated subjects, resulting in relative treatment differences of 12% and 39%, respectively. In the valacyclovir arm the time to lesion crusting was faster than the FV-100 arms; however, no differences were noted between the treatment arms on time to full lesion healing. The overall tolerability and side effect profile of both doses of FV-100 was comparable to valacyclovir.
Epiphany BioSciences released positive results from a phase IIb trial of valomaciclovir for the treatment of Herpes Zoster (shingles). This double-blind, non-inferiority study enrolled 373 subjects who were randomized into to receive 1, 2 or 3 grams of once-daily valomaciclovir or standard of care (valacyclovir: 1 gram, three times per day). The primary endpoint was non-inferiority of once-daily valomaciclovir compared to thrice-daily valacyclovir in terms of time to complete crusting of the shingles rash. The two highest doses of once-daily valomaciclovir met the primary endpoint, and the highest dose demonstrated superiority to valacyclovir (p<0.007). Valomaciclovir was also non-inferior to valacyclovir in the secondary endpoints of time to complete pain resolution, time to rash resolution and time to cessation of new lesion formation. There were no differences in significant adverse events between the treatment arms.
Janus announced positive results from a phase II trial of JA-001 for the treatment of Herpes Zoster (Shingles). Subjects with a primary Shingles episode received JA-001 or placebo applied twice daily for 7 days. After the first three days of treatment all subjects received Valtrex oral standard of care treatment concomitantly with JA-001 or placebo. Results revealed a 30% reduction in rash area in the JA-001 treatment group compared to placebo in the initial 3 days of treatment, prior to initiation of Valtrex. The rashes in the placebo group had a much higher median percentage (60%) in transitioning through the crusting stage than rashes in the JA-001 group (15%), which healed without crusting (p=0.07). In addition, subjects receiving JA-001 showed signs of a marked reduction in severity of acute, nociceptive Zoster-associated pain in the first month, when compared to placebo, as evaluated by the Brief Pain Inventory (BPI). Based on these results, Janus plans to initiate a phase II/III trial of JA-001 in Q1 2007.