Epiphany Biosciences announces positive results from its phase 2b trial in shingles

Epiphany Biosciences announces positive results from its phase 2b trial in
shingles 

The Epiphany Biosciences press release reads as follows;


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 (pvalue < 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 clearly demonstrate that once-daily valomaciclovir is not
only more convenient than three times daily valacyclovir for the treatment of
herpes zoster, 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 significant adverse event differences 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 Bioscience's 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 licensed from the Swedish biotech company Medivir AB.
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).

For additional information, please contact
Rein Piir, CFO & VP Investor Relations, Medivir +46 708 537 292.

For more information on Medivir, please see the company website: www.medivir.se