Inhibitex, Inc. (NASDAQ:INHX) (the “Company”) today announced
several recent clinical and corporate developments, including
top-line safety and antiviral data from its ongoing clinical trial
designed to evaluate additional doses of INX-189, an oral
nucleotide polymerase inhibitor being developed to treat chronic
infections caused by hepatitis C virus (HCV), administered as
monotherapy or in combination with ribavirin (RBV) for seven
days.
“We believe the significant increase in antiviral activity
demonstrated with 100 mg INX-189 in combination with RBV, as
compared to 100 mg INX-189 dosed as monotherapy, further confirms
the antiviral synergy between INX-189 and RBV that we have
consistently observed in preclinical and clinical results to-date,”
stated Dr. Joseph Patti, Senior Vice President and CSO of
Inhibitex, Inc. “We look forward to further exploring this
antiviral synergy with 200 mg of INX-189 and expanding the scope of
our ongoing and planned Phase 2 clinical trials to include
interferon-free combinations of INX-189 with other antiviral agents
in HCV genotype 1, 2, and 3 patients in 2012.”
Recent Corporate Developments
INX-189 for Chronic Hepatitis C – The Company today
reported top-line safety and antiviral data from an ongoing Phase
1b extension trial of INX-189, which is designed to further
evaluate the safety, tolerability, pharmacokinetics and antiviral
activity of various doses of INX-189, administered as monotherapy
or in combination with RBV, for seven days in treatment-naïve
patients infected with chronic HCV genotype 1. In the ongoing
trial, 100 mg INX-189, dosed once-daily for seven days in
combination with RBV, continued to demonstrate potent and
dose-dependent synergistic antiviral activity with a median HCV RNA
reduction from baseline of -3.79 log10 IU/mL. Further, 100 mg
INX-189 in combination with RBV was well tolerated and there were
no serious adverse events. For comparison purposes, in a clinical
trial completed earlier this year, 100 mg INX-189 dosed as
monotherapy once-daily for seven days resulted in a median -2.53
log10 IU/mL reduction in HCV RNA levels. In this same clinical
trial, the Company also reported antiviral data indicating that
INX-189, when dosed once-daily at 9 and 25 mg in combination with
RBV for seven days, demonstrated dose-dependent, synergistic
antiviral activity.
The Company also reported today that, subject to regulatory
review, it plans to further expand its ongoing Phase 1b extension
trial to evaluate once-daily doses of 200 mg INX-189 in combination
with RBV; 300 mg INX-189 as monotherapy; and 200 mg INX-005 (a
single isomer of INX-189) as monotherapy, respectively, for seven
days. The Company anticipates that the Phase 1b extension trial
will be completed in the first quarter of 2012.
Additionally, the Company reported that it plans to submit a
protocol amendment this quarter to its ongoing Phase 2 study in
genotype 2 and 3 HCV-infected patients to include the evaluation of
100 mg and 200 mg of INX-189 dosed once-daily in combination with
RBV for 12 weeks.
Financing Activity – The Company reported today that it
had recently sold a total of 1,949,015 shares of common stock at an
average price per share of $10.25 for total gross proceeds of
$19,983,396 through its at-the-market (ATM) financing vehicle. The
Company entered into a $20 million ATM financing arrangement with
McNicoll, Lewis & Vlak LLC (MLV) in November 2010, which
provides it the opportunity to sell registered shares into the open
market through MLV from time-to-time under its effective shelf
registration. After commissions, the Company received $19,383,274
in net proceeds. The intended use of the net proceeds is to support
the expansion of the Company’s planned Phase 2 program for INX-189
in 2012 and for general corporate purposes.
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 two Phase
2 development programs for which it has retained all future rights:
INX-189, a nucleotide polymerase inhibitor in development for the
treatment of chronic HCV infections, and FV-100, a nucleoside
analogue in development for the treatment of shingles-associated
pain. 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 a staphylococcal vaccine, which is currently being
evaluated in a Phase 1/2 clinical trial. 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 plan to evaluate the
safety, tolerability, pharmacokinetics and antiviral activity of
additional doses of INX-189 and INX-005, administered as
monotherapy or in combination with ribavirin for seven days in its
ongoing Phase 1b extension trial; the Company’s plan to submit a
protocol amendment to expand the scope of its ongoing and planned
Phase 2 development program of INX-189 to include interferon-free
combinations in HCV genotype 1, 2, and 3 patients in 2012; the time
in which the Company anticipates completing enrollment in its
ongoing Phase 1b extension trial; and the intended use of net
proceeds from the Company’s recent financing activities, 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: the Company, the FDA, a data safety
monitoring board, or an institutional review board delaying,
limiting, suspending or terminating the clinical development of
INX-189 at any time for a lack of safety, tolerability, biologic
activity or efficacy, commercial viability, regulatory issues, or
any other reason; the safety, tolerability and antiviral results
achieved in small numbers of patients to-date not being repeatable
in larger scale clinical trials; the Company’s ability to secure
and use qualified third-party clinical and preclinical research and
data management organizations to assist it in initiating and
conducting planned clinical trials; third-party contract
manufacturers not fulfilling their contractual obligations or
otherwise performing satisfactorily in the future; the Company’s
ability to manufacture and maintain sufficient quantities of
preclinical and clinical trial material on-hand to complete planned
preclinical studies and clinical trials on a timely basis; and
other cautionary statements contained elsewhere herein and in its
Annual Report on Form 10-K for the year ended December 31, 2010 and
its Quarterly Report on Form 10-Q for the period ended March 31,
2011, June 30, 2011 and September 30, 2011 as filed with the
Securities and Exchange Commission, or SEC, on March 16, 2011, May
6, 2011, August 9, 2011 and November 8, 2011, respectively. 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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