Inhibitex, Inc. (NASDAQ: INHX), a biopharmaceutical company
focused on the development of products to treat serious infectious
diseases, reported today that it has completed its Phase I clinical
trials of FV-100, a highly potent and fast-acting oral compound
being developed to treat shingles (herpes zoster). The recently
completed trials include both a multiple ascending dose study in
subjects aged 18-55 and a separate study conducted in subjects 65
years of age or older.
The blinded, placebo controlled multiple ascending dose trial
was designed to evaluate the safety and pharmacokinetics of five
oral doses of FV-100 (100, 200, 400 and 800 mg administered once a
day and 400 mg administered twice daily, each for seven days) in
healthy subjects aged 18-55. Each dose cohort consisted of six
subjects that received FV-100 and two that received placebo.
The blinded, placebo controlled trial in elderly subjects aged
65 years and older was comprised of two cohorts. In the first
cohort, 10 subjects received a single 400 mg dose of FV-100 and two
received placebo. In the second cohort, 10 subjects received 400 mg
of FV-100 administered once daily for seven consecutive days and
two received placebo. The purpose of this study was to compare the
safety and pharmacokinetics of FV-100 in older individuals, which
represent approximately half of all shingles patients, to those of
younger subjects from the Company�s single and multiple ascending
dose Phase I trials.
The Company reported that in both trials there were no serious
adverse events reported and FV-100 appeared to be well tolerated at
all dose levels. Additionally, pharmacokinetic data demonstrated
that all doses maintained mean drug plasma levels of the active
form of FV-100 that exceeded the EC50 for approximately 24 hours,
supporting the potential for once-a-day dosing in future trials.
Finally, the pharmacokinetic profile of FV-100 in elderly subjects
was similar to that of younger subjects. These safety and
pharmacokinetic findings are consistent with those observed in the
Company�s Phase I single ascending dose trial, the results of which
were reported at ICAAC last year.
The Company plans to present the full data from these trials at
a scientific conference later this year.
"We are very pleased with the favorable safety and
pharmacokinetic results from our Phase I trials of FV-100," stated
Russell H. Plumb, president and chief executive officer of
Inhibitex. "We believe these data support advancing the compound
into a well-powered, human proof of concept Phase II trial in
shingles patients. Subject to FDA review of our Phase I data and
proposed protocol, we look forward to initiating such a trial as
soon as practical."
The Company also reported that it has selected lead candidates
from its series of proprietary HCV nucleoside polymerase inhibitors
for evaluation in advanced preclinical and Investigational New Drug
application (IND) enabling studies. The decision to proceed into
these advanced studies was based on favorable results from
completed in vitro and in vivo studies, in which the candidates
have demonstrated excellent potency in the HCV replicon assay,
rapid conversion to triphosphate in human hepatocytes, triphosphate
levels in the livers of orally dosed primates and rodents that
exceed the EC90, and a favorable in vitro toxicity profile. Subject
to the successful completion of IND-enabling studies, the Company�s
goal is to initiate a first-in-man study in the first half of
2010.
About Shingles
Shingles, also known as herpes zoster, is an infection caused by
the reactivation of varicella zoster virus (VZV), the same virus
that causes chicken pox. Worldwide, it is estimated that there are
greater than 2.5 million cases of shingles each year. Shingles is
generally characterized by skin lesions, acute infection-related
pain, and in many cases post herpetic neuralgia (PHN), a painful
and sometimes debilitating condition resulting from nerve damage
caused by VZV that can last for several months or more. While
shingles can develop in adolescents or adults of any age, it occurs
predominantly in those 40 years of age and older.
About FV-100
Published in vitro studies have demonstrated that FV-100, an
orally available nucleoside analogue, is more potent against VZV,
and can inhibit its replication substantially faster, than any
other antiviral agent currently approved for the treatment of
shingles. Inhibitex believes these characteristics provide the
potential for FV-100 to reduce the incidence and severity of
shingles-related symptoms, including acute pain and PHN.
About HCV
Hepatitis C is a disease of the liver caused by the hepatitis C
virus (HCV). It is estimated that approximately 4 million
Americans, and 170 million individuals worldwide, are infected with
HCV. Hepatitis C leads to chronic liver disease, cirrhosis and
cancer, and is the leading cause of liver transplant in the United
States.
Inhibitex is developing phosphoramidate nucleoside analogues, or
pronucleotides (protides). The Company believes that protides
possess several pharmacological advantages over their parent
nucleoside, which include a significant increase in antiviral
activity, higher concentrations of the triphosphate in liver, and
potentially less toxicity due to reduced systemic exposure.
About Inhibitex
Inhibitex, Inc., headquartered in Alpharetta, Georgia, is a
biopharmaceutical company focused on developing products to treat
and prevent serious infectious diseases. In addition to FV-100, the
Company�s preclinical pipeline includes a series of HCV nucleoside
polymerase inhibitors and HIV integrase inhibitors. Inhibitex has
also licensed its proprietary MSCRAMM� protein technology to Wyeth
for the development of staphylococcal vaccines and to 3M for the
development of diagnostics.
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 statements of historical facts, including those related
to the Company�s plan to present the full data from its recently
completed Phase I trials of FV-100 at a scientific conference later
this year; the potential for FV-100 to be dosed once-a-day and to
further reduce the incidence and severity of shingles-related
symptoms, including the incidence and severity of acute pain and
PHN; the Company�s plan to initiate a proposed Phase II clinical
trial of FV-100 in shingles patients and the proposed design of
such a trial; the Company�s goal to initiate a first-in-man study
with an HCV polymerase inhibitor in the first half of 2010; and the
potential for protides to possess several pharmacological
advantages over their parent nucleoside are forward-looking
statements,. These plans, intentions, expectations, or time
estimates may not actually be achieved and various important
factors could cause actual results or events to differ materially
from the forward-looking statements that the Company makes,
including risks that the results of future clinical studies may not
confirm prior findings or support the further development of
FV-100; IND enabling studies may not confirm prior preclinical
findings or support the advancement of a HCV polymerase inhibitor
into clinical trials; the Company not obtaining regulatory approval
to advance the development of FV-100 or a HCV polymerase inhibitor;
either the Company, the U.S. Food and Drug Administration (FDA) or
an investigational review board (IRB) suspending or terminating the
clinical development of FV-100 for safety or other reasons; FV-100
not proving to be efficacious in reducing shingles-related symptoms
in future clinical trials; and other cautionary statements
contained elsewhere herein and in its Annual Report on Form 10-K
for the year ended December 31, 2007, as filed with the Securities
and Exchange Commission, or SEC, on March 14, 2008, and its
Quarterly Report on Form 10-Q for the quarter ended September 30,
2008 as filed with the SEC on November 10, 2008. 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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