SAN FRANCISCO, Nov. 18 /PRNewswire/ -- Epiphany Biosciences announced results from its Phase 2b dose-ranging study of EPB-348 (valomaciclovir) in patients with shingles (herpes zoster) infection. The study's 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 double-blinded study enrolled 373 patients, randomized into 3 arms: 1 gram of once-daily EPB-348, 2 grams of once-daily EPB-348, thrice-daily valacyclovir (1 gram, three times per day). Eighteen patients also received 3 grams of once-daily EPB-348.
Dose-dependent trends to improved pain resolution in the subset of treated patients who were over 50 years old and trends to faster resolution of severe pain in patients of all ages were seen in the higher dose EPB-348 treatment arms when compared to valacyclovir. All doses of EPB-348 showed improvement over valacyclovir for patients presenting for first treatment towards the end of the 72 hour treatment window. Currently-approved shingles treatments are effective only within the first 72 hours of rash appearance.
There were no differences in significant adverse events between valomaciclovir and valacyclovir groups. The most common adverse event in all patient groups was nausea. No patient discontinued treatment due to adverse events related to EPB-348 use.
EPB-348 has also been shown to be effective against acute infectious mononucleosis, for which there is no FDA-approved treatment, in a Phase 2a study. Data from this study were presented during the 2009 ICAAC meeting in San Francisco.
EPB-348 is a potent inhibitor of herpes viruses, including the varicella zoster and Epstein-Barr viruses. It has been studied clinically in both shingles and infectious mononucleosis.
Shingles is a reactivation of the varicella zoster virus, the same virus that causes chickenpox in children, and infects over 90% of the US adult population. An estimated 5 in 1000 people suffer from shingles in the US every year, and 20% of all individuals are estimated to experience at least one episode of shingles during their lifetime. The risk of shingles outbreak dramatically increases with age.
About Epiphany Biosciences
Contact: Christian Hofmann, bd@epiphanybio.com
Epiphany Biosciences, Inc.
