Inhibitex Initiates Phase 1b Multiple Ascending Dose Trial of INX-189 in Patients with Chronic Hepatitis C
November 01 2010 - 7:00AM
Business Wire
Inhibitex, Inc. (NASDAQ: INHX), announced today that it has
initiated a Phase 1b, multiple ascending dose (MAD) clinical trial
of INX-189, its nucleotide polymerase inhibitor in development for
the treatment of chronic infections caused by hepatitis C virus
(HCV). The trial, which is being conducted under an IND in the
United States, is a double-blind, placebo-controlled, dose
escalation study designed to evaluate the safety, tolerability,
pharmacokinetics and anti-viral activity of INX-189 administered
orally once daily for seven days in treatment naïve patients with
HCV genotype 1. Each treatment cohort will include 10 patients,
eight of which will receive INX-189 and two of which will receive
placebo. The first cohort in the Phase 1b study will receive 9 mg
of INX-189 once daily. In addition to evaluating INX-189 as
monotherapy, the Company plans to evaluate two dose levels of
INX-189 administered once daily for seven days in combination with
ribavirin, which is one of the drugs currently approved for the
treatment of HCV. The dose levels of INX-189 to be evaluated in
combination with ribavirin will be determined based upon the
results of the monotherapy cohorts.
“The initiation of this proof of concept study in patients with
chronic hepatitis C marks an important milestone in the clinical
development of INX-189,” stated Dr. Joseph Patti, Senior Vice
President and Chief Scientific Officer of Inhibitex, Inc. “We
believe that dosing INX-189 both as monotherapy and in combination
with ribavirin in this study will enhance our ability to assess the
anticipated anti-viral synergies of the two agents and allow us to
better define the most appropriate doses of INX-189 to evaluate in
future clinical trials.”
About HCV and INX-189
Hepatitis C is a disease of the liver caused by HCV. It is
estimated that over 4 million Americans and 170 million individuals
worldwide are infected with HCV, the majority of which represent
chronic infections that can cause liver disease, cirrhosis and
cancer, and is the leading cause of liver transplants in the United
States.
Inhibitex is developing a series of proprietary nucleotide
inhibitors that target the RNA-dependent RNA polymerase (NS5b) of
HCV. The Company believes that its nucleotides possess several
pharmacological advantages over other HCV nucleosides or
nucleotides in clinical development, including a more efficient
conversion into their active anti-viral form, a more favorable
resistance profile, and anti-viral synergy when used in combination
with ribavirin. INX-189 is a protide of a 2’-C-methylguanosine
analogue, which, based on in vitro data, the Company believes is
the most potent HCV nucleotide polymerase inhibitor currently in
clinical development. The Company believes that preclinical and
clinical studies of INX-189 completed to-date support its potential
as a potent, once-daily oral therapy amenable to combination with
other anti-virals for the treatment of patients with all known
genotypes of HCV.
About Inhibitex
Inhibitex, Inc. is a biopharmaceutical company focused on
developing products to prevent and treat serious infectious
diseases. The Company’s clinical stage pipeline includes FV-100, a
bicyclic nucleoside inhibitor in Phase II development for the
treatment of shingles, and INX-189, a nucleotide polymerase
inhibitor in 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 Company’s plans to evaluate
INX-189 as monotherapy for seven days and in combination with
ribavirin in the Phase 1b study; that dosing INX-189 in combination
with ribavirin will enhance the Company’s ability to assess the
anticipated anti-viral synergies of the two agents and better
define the most appropriate doses of INX-189 to evaluate in future
clinical trials; the Company’s belief that INX-189 is the most
potent HCV nucleotide polymerase inhibitor in clinical development;
the Company’s belief that its nucleotides possess several
pharmacological advantages over other nucleosides or nucleotides in
clinical development; and the results of preclinical studies of
INX-189 supporting its potential as a highly potent, once-daily
oral therapy amenable to combination with other anti-virals for the
treatment of patients with all known genotypes of HCV, 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; the results of ongoing or future preclinical or clinical
studies of INX-189 not supporting its further development for lack
of safety, tolerability, anti-viral activity, or any other reason,
or not demonstrating any significant benefits over nucleosides
alone or other nucleotide prodrugs; INX-189 not demonstrating
anti-viral activity as monotherapy or any anti-viral synergies with
ribavirin in the Phase 1b trial; either the Company, the FDA, a
data safety monitoring board or an investigational review board
suspending or terminating the clinical development of INX-189 at
any time for lack of safety, tolerability, anti-viral activity, or
any other reason; obtaining, maintaining and protecting the
intellectual property incorporated into and supporting the
commercial viability of the Company’s product candidates; 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
June 30, 2010, as filed with the SEC on August 12, 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.
Inhibitex, Inc. (MM) (NASDAQ:INHX)
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