Inhibitex Receives Fast Track Designation for INX-189 for the Treatment of Chronic Hepatitis C Infections
February 11 2011 - 7:00AM
Business Wire
Inhibitex, Inc. (Nasdaq: INHX) today reported that the U.S. Food
and Drug Administration (“FDA”) has designated the investigation of
INX-08189 (“INX-189”), a potent guanosine nucleotide polymerase
inhibitor for the treatment of chronic hepatitis C viral infection,
as a Fast Track development program. Under the FDA Modernization
Act of 1997, Fast Track programs are designed to facilitate the
development and expedite the review of new drugs that are intended
to treat serious or life threatening conditions and that
demonstrate the potential to address unmet medical needs. The
characteristics of INX-189 that contributed to it being granted
Fast Track status include a high genetic barrier to resistance, its
pan-genotypic activity, and once-daily oral dosing.
“The FDA’s fast track designation for INX-189 is reflective of
its unique features and the need for novel antiviral drugs that
demonstrate the potential to provide better clinical outcomes and
improved tolerability for the millions of individuals suffering
from chronic hepatitis C infection,” commented Dr. Joseph Patti,
Inhibitex’s Chief Scientific Officer and Senior Vice President of
Research and Development.
The Company reported interim data from the first two cohorts of
its ongoing Phase 1b clinical trial of INX-189 on January 9, 2011
and anticipates completing this trial by the end of the first
quarter of 2011.
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. Chronic hepatitis C 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. INX-189 is a protide of a 2’-C-methylguanosine analogue. The
Company believes that preclinical and clinical studies of INX-189
completed to-date support its potential as a potent, once-daily,
low dose oral therapy amenable to combination with other antivirals
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. In addition to INX-189, the Company’s clinical stage
antiviral pipeline includes FV-100, a bicyclic nucleoside inhibitor
in Phase II development for the prevention and reduction of
shingles-associated pain. 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 belief that the
results of preclinical and clinical studies of INX-189 to-date
support 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 alone or in combination with other anti-viral
compounds not supporting its further development for lack of
safety, tolerability, anti-viral activity, or any other reason;
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 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.
Inhibitex, Inc. (MM) (NASDAQ:INHX)
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