Epiphany Announces Positive Results from Its Phase 2b Trial in Shingles.
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.
Once-daily EPB-348 at two grams met its primary endpoint of
non-inferiority to valacyclovir. Valomaciclovir (EPB-348) 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. The highest dose of
valomaciclovir (3 grams once daily) demonstrated superiority to
valacyclovir with regards to the primary endpoint (p-value <
0.007).
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.
"These Phase 2 data indicate that once-daily valomaciclovir
could be more convenient than three times daily valacyclovir for
the treatment of herpes zoster, and it is equally safe. Moreover,
the 3 gram dose of valomaciclovir was superior to valacyclovir in
terms of clinical efficacy. Therefore, Phase 3 studies with larger
numbers of patients are clearly indicated," said Stephen Tyring,
MD, PhD, Clinical Professor at the University of Texas Health
Sciences Center, the lead investigator of the study.
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.
"We are pleased with our Phase 2b results that demonstrate
once-daily EPB-348 is both safe and active in treating shingles. We
are encouraged by the trends to better pain resolution and less
severe pain in the valomaciclovir-treated patients. We anticipate
that EPB-348 may be the first once-a-day shingles drug with a wider
treatment window and a reduction in both the incidence and severity
of shingles associated pain. We look forward to demonstrating these
and other additional benefits in Phase 3 clinical trials," said
Fred Volinsky, MD, Epiphany Biosciences' CEO.
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.
About EPB-348
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.
About Shingles
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.
Shingles manifests itself as a painful rash that develop into
blisters, often mainly on one side of the body. The normal healing
process takes about four weeks. Shingles pain is frequently
observed as zoster associated pain (ZAP) and post-herpetic
neuralgia (PHN). ZAP is present during the initial disease
outbreak. PHN is a persistent pain that is present in some patients
long after the lesions have resolved.
About Epiphany Biosciences
Epiphany Biosciences is a privately-held company developing
therapeutic products and diagnostic technologies that treat or help
prevent the spread of pathogenic viruses, including varicella
zoster virus (VZV), Epstein-Barr Virus (EBV) and hepatitis C virus
(HCV).
Contact: Christian Hofmann, bd@epiphanybio.com
Source: Epiphany Biosciences, Inc.
CONTACT: Christian Hofmann, bd@epiphanybio.com, for
Epiphany
Biosciences, Inc.
Web Site: http://www.epiphanybio.com/
