Inhibitex, Inc. (Nasdaq: INHX) today reported top-line safety
and efficacy data from its Phase II clinical trial of FV-100, an
oral antiviral compound being developed to treat herpes zoster,
more commonly referred to as shingles. The study was the first
clinical trial to assess the antiviral activity of FV-100, included
350 shingles patients and compared two once-daily doses of FV-100
(200 mg and 400 mg) to an active control, valacyclovir, one of the
most commonly-used antiviral drugs to treat shingles. Valacyclovir
was administered three times per day at 1,000 mg per dose, or 3,000
mg 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).
There were also favorable treatment differences observed for key
secondary pain endpoints, including the reduction in the severity
and duration of shingles-associated pain over 90 days (BOI90 AUC)
and the incidence of post herpetic neuralgia, or PHN. The treatment
differences observed between either of the FV-100 cohorts and the
valacyclovir-treated subjects were not statistically significant.
FV-100 was generally well tolerated at both dose levels, and
demonstrated a similar adverse event profile as compared to
valacyclovir.
“FV-100 has now demonstrated, in a well controlled trial,
favorable treatment outcomes in shingles patients with the added
benefit of once-daily dosing,” stated Stephen Tyring, MD, PhD, a
virologist at the Center for Clinical Studies in Webster, Texas and
principal investigator of the Phase II trial. “These data support
the potential of FV-100 as an effective, well tolerated, once-daily
therapy for the treatment of shingles.”
“We believe the tolerability profile and treatment advantages
observed across the various pain endpoints in this proof-of-concept
study confirm FV-100’s potential as a standard of care therapy for
the treatment of shingles,” stated Russell H. Plumb, CEO and
President of Inhibitex, Inc. “The treatment outcomes observed with
the higher dose of FV-100 for the reduction of longer-term
shingles-associated pain, and in particular, preventing PHN, are
especially encouraging. Upon our review of the complete data set
from the trial, we will evaluate the clinical and regulatory
pathways for FV-100 and determine the next steps in its
development.”
FV-100 Efficacy Summary
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. The three treatment arms were
well-balanced with regard to demographics and baseline
shingles-associated pain levels.
The following table reflects the treatment outcomes among the
three treatment arms with respect to the key shingles-associated
pain endpoints on the modified intent-to-treat population:
Primary Endpoint Key Secondary Pain
Endpoints Cohort (N)
Least Squares MeanBOI30 days AUC ±
S.E.
Least Squares MeanBOI90days AUC ± S.E.
Incidence of PHN(%)
200 mg FV-100(N=107)
114.49 ± 6.24 221.53 ± 19.51
17.8
400 mg FV-100(N=113)
110.31 ± 6.08 196.94 ± 19.01
12.4
3000 mgvalacyclovir(N=109)
117.96 ± 6.25 229.59 ± 19.55
20.2
FV-100 Safety Summary
A comparison of adverse events between the three treatment arms
in the study demonstrated that the overall tolerability and side
effect profile of both doses of FV-100 was comparable to
valacyclovir. All three treatment arms showed a relatively low
proportion of adverse events and serious adverse events. In the 400
mg FV-100 dose group, the most common adverse events were headache
(reported in 13% of patients) and nausea (9%); no patient
discontinued because of headache and one patient terminated due to
nausea (grade 1). The most common adverse events in the
valacyclovir cohort were nausea (6%) and upper abdominal pain
(5%).
The following table summarizes the top-line adverse event
findings from the trial:
Number (%) of PatientsReporting:
200 mg FV-100(N=117)
400 mg FV-100(N=117)
3000 mg valacyclovir(N=116)
Any AE 46.2 54.7 42.2
Treatment-Related AEs 20.5 25.6
19.8 Discontinuation of Drug for AE 1.7
1.7 1.7 SAEs 0 4.3
3.4 Treatment-Related SAEs 0
0 1.7
About the Phase II Trial Design
The Phase II clinical trial was the first clinical trial of
FV-100 in shingles patients. The trial was a well-controlled,
double-blind study comparing FV-100 to an active control
(valacyclovir). A total of 350 patients, aged 50 years and older
who had shingles-associated pain and presented to the clinic within
72 hours of their first shingles lesion appearing, were equally
randomized to one of three treatment arms: 200 mg FV-100
administered once daily for seven days; 400 mg FV-100 administered
once daily for seven days; or 1,000 mg valacyclovir administered
three times per day for seven days. In addition to further
evaluating its safety and tolerability, the objectives of the trial
were to evaluate the potential therapeutic benefit of FV-100 in
reducing (i) the severity and duration of shingles-associated pain,
(ii) the incidence of PHN, (iii) the time to lesion crusting and
healing and, (iv) the use of concomitant pain medications, as
compared to valacyclovir. The primary efficacy analysis was
conducted on the modified intent-to-treat population, which
included all intent-to-treat subjects but excluded subjects whose
lesions were PCR (-) for varicella zoster virus and PCR (+) for
herpes simplex virus. The efficacy endpoints were calculated using
a last observation carried forward methodology.
Conference Call and Webcast Information
Inhibitex’s management team will discuss the top-line data and
results of the Phase II trial of FV-100 via a webcast and
conference call today at 4:30 p.m. EST. To access the conference
call, dial (877) 407-9210 (domestic) or (201) 689-8049
(international). A replay of the call will be available from 11:00
a.m. EST on December 14 until January 13, 2011 at midnight. To
access the replay, please dial (877) 660-6853 (domestic) or (201)
612-7415 (international) and reference the account # 286 and the
conference ID # 362868. A live audio webcast of the call and the
archived webcast will be available under the News and Events
category on the Inhibitex website at http://www.inhibitex.com.
About Shingles and FV-100
Shingles is an infection caused by the reactivation of the
varicella zoster virus (VZV), the same virus that causes chicken
pox. Worldwide, it is estimated that more than 2.5 million new
cases of shingles occur each year, and that one in four adults will
suffer from shingles during their lifetime. While shingles can
develop in adolescents or adults of any age, it occurs
predominantly in individuals 40 years of age and older. Shingles is
generally characterized by skin lesions or rash, acute
infection-related pain, and in many cases, PHN, which is a painful
and often debilitating chronic complication that impacts
approximately one out of every five shingles patients. PHN can last
for months or possibly years, and has been shown to have a
measurable and significant impact on patients’ quality of life and
functional status.
About Inhibitex
Inhibitex, Inc. is a biopharmaceutical company focused on
developing products to prevent and treat serious infectious
diseases. In addition to FV-100, the Company’s clinical stage
pipeline includes INX-189, a nucleotide polymerase inhibitor in
Phase 1b development for the treatment of chronic infections caused
by hepatitis C virus (HCV). The Company also has additional HCV
nucleotide polymerase inhibitors in various stages of preclinical
development, and has licensed the use of its proprietary MSCRAMM®
protein platform to Pfizer for the development of active
staphylococcal vaccines. For additional information about the
Company, please visit www.inhibitex.com.
Safe Harbor Statement
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that involve substantial risks and uncertainties. All statements,
other than historical facts included in this press release,
including statements regarding the potential of FV-100 as a
well-tolerated, effective low dose, once-daily therapy for the
treatment of shingles; FV-100’s potential as a standard of care
therapy for the treatment of shingles; and the Company’s intent to
evaluate the clinical and regulatory pathways for FV-100 and
determine the next steps in its development, are forward looking
statements. These intentions, expectations, or results may not be
achieved in the future and various important factors could cause
actual results or events to differ materially from the
forward-looking statements that the Company makes, including the
risk that further assessment of the data from this or future
clinical trials, communications with regulatory authorities, or
other factors may result in the Company not pursuing the
development of FV-100, and other cautionary statements contained
elsewhere herein and in its Annual Report on Form 10-K for the year
ended December 31, 2009, as filed with the Securities and Exchange
Commission, or SEC, on March 26, 2010, and its Quarterly Report on
Form 10-Q for the quarter ended September 30, 2010, as filed with
the SEC on November 15, 2010. Given these uncertainties, you should
not place undue reliance on these forward-looking statements, which
apply only as of the date of this press release.
There may be events in the future that the Company is unable to
predict accurately, or over which it has no control. The Company's
business, financial condition, results of operations and prospects
may change. The Company may not update these forward-looking
statements, even though its situation may change in the future,
unless it has obligations under the Federal securities laws to
update and disclose material developments related to previously
disclosed information. The Company qualifies all of the information
contained in this press release, and particularly its
forward-looking statements, by these cautionary statements.
Inhibitex® and MSCRAMM® are registered trademarks of Inhibitex,
Inc.
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