Inhibitex Successfully Completes Phase 1a Trial of INX-189
September 01 2010 - 7:00AM
Business Wire
Inhibitex, Inc. (Nasdaq: INHX), announced today that it has
successfully completed a Phase1a, first-in-man, single ascending
dose trial of INX-189, its nucleotide polymerase inhibitor in
development for the treatment of chronic hepatitis C (HCV)
infections. In this trial, 42 healthy volunteers received either a
single oral dose of INX-189, ranging from 3 mg to 100 mg, or
placebo. The Company plans to present detailed results from this
trial during a future scientific meeting. Preliminary data from the
trial are as follows:
- INX-189 was generally well
tolerated at all dose levels;
- No drug-related serious adverse
events;
- No dose-related trends in
frequency or type of adverse events; adverse events occurring in
more than one subject were headache and nasal congestion;
- No grade II or higher laboratory
abnormality adverse events or clinically significant changes in
ECGs; and
- Pharmacokinetic data supports
INX-189’s potential for once daily (QD) dosing.
“We are encouraged with the initial safety and pharmacokinetic
profile of INX-189 in this first-in-man trial,” stated Dr. Joseph
Patti, Senior Vice President and Chief Scientific Officer of
Inhibitex, Inc. “Based upon the pharmacokinetics observed in this
study, we continue to believe that INX-189 has the potential to
demonstrate antiviral activity with a low once-daily dose, and we
look forward to assessing its ability to reduce HCV RNA viral loads
in patients with chronic hepatitis C in a Phase 1b multiple
ascending dose trial we plan to start in the fourth quarter.”
About Inhibitex
Inhibitex, Inc., headquartered in Alpharetta, Georgia, is a
biopharmaceutical company focused on developing products to prevent
and treat serious infectious diseases. The Company’s pipeline
includes FV-100, which is in Phase II clinical development for the
treatment of shingles, and INX-189, a nucleotide polymerase
inhibitor in development for the treatment of chronic hepatitis C
infections. The Company also has additional HCV nucleotide
polymerase inhibitors in preclinical development and has licensed
the use of its proprietary MSCRAMM® protein platform to Pfizer for
the development of 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 present
detailed results from the Phase 1a trial during a future medical
meeting and its intention to initiate a Phase 1b multiple ascending
dose trial in the fourth quarter of 2010 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 of: either the Company, the FDA, a data and safety monitoring
board, or an investigational review board delaying, suspending or
terminating the clinical development of INX-189 for a lack of
safety or antiviral activity, manufacturing-related issues,
questions or issues regarding the design of the planned Phase 1b
clinical study of INX-189, or any other reasons; the Company
obtaining, maintaining and protecting the intellectual property
incorporated into and supporting the commercial viability of
INX-189; 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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