Inhibitex, Inc. (Nasdaq: INHX) today reported positive
preliminary interim safety and antiviral data from the first two
monotherapy cohorts of its ongoing Phase 1b clinical trial of
INX-189, an oral NS5b nucleotide inhibitor being developed to treat
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 antiviral activity of INX-189, administered
orally once-daily for seven days, for the treatment of HCV genotype
1 treatment naïve patients. Each treatment cohort in the study is
comprised of 10 patients, eight that receive INX-189 and two that
receive placebo. In addition to the 9 mg and 25 mg dose cohorts,
the Company plans to enroll up to three more INX-189 monotherapy
cohorts in the study, as well as two cohorts that will receive
different doses of INX-189 once daily for seven days in combination
with ribavirin.
INX-189, dosed once-daily at 9mg and 25mg for seven days,
demonstrated potent antiviral activity with a mean HCV RNA
reduction from baseline levels of -0.71 and -1.03 log10 IU/mL,
respectively. The mean HCV RNA decline from baseline levels
observed in patients that received placebo was -0.06 log10 IU/mL.
The HCV RNA declines from baseline were statistically significant
from placebo, with p-values of 0.0156 and 0.0006 in the 9 mg and 25
mg cohorts, respectively. In addition to the mean reductions in
viral load, clinically meaningful decreases in alanine transaminase
(ALT) levels were observed for patients receiving INX-189 at both
dose levels and no patients experienced viral breakthrough.
Cohort
Mean HCV log10 IU/mL RNAViral Load Decline
after 3 doses
Mean HCV log10 IU/mL RNAViral Load Decline
after 7 doses
# of Patients with >1 log declinein HCV
log10 IU/mL RNA
25 mgINX-189 QD(n=8)
-0.88 -1.03 5
9 mgINX-189 QD(n=7)
-0.47 -0.71 1
Placebo(n=4)
-0.05 -0.03 0
Preliminary assessments of the data available from the first two
cohorts in the Phase 1b study indicate that INX-189 was well
tolerated. There were no serious adverse events reported, no
discontinuations due to an adverse event, and no adverse events
related to changes in clinical laboratory evaluations. All reported
adverse events were mild or moderate and were not dose dependent.
In addition, the pharmacokinetics of the 9mg and 25mg doses in
HCV-infected patients were comparable to those observed in healthy
volunteers, and continue to support the evaluation of INX-189 as a
once-daily therapy.
“We are pleased with the interim results of the trial to-date
and the rapid and potent antiviral activity demonstrated at these
low doses of INX-189,” commented Joseph M. Patti, Ph.D.,
Inhibitex’s CSO and Senior Vice-President of Research. “We look
forward to completing the remaining monotherapy cohorts and
evaluating the potential antiviral synergies of INX-189 in
combination with ribavirin in this ongoing study, and anticipate
reporting additional safety, antiviral and pharmacokinetic data
from the study upon its completion later this quarter.”
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. 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
oral therapy amenable to combination with other antivirals for the
treatment of patients with all known genotypes of HCV.
In a Phase 1a study, 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 demonstrated the following:
- INX-189 was 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, nasal congestion, ecchymosis, and
presyncope;
- No grade II or higher laboratory
abnormality adverse events; and
- Pharmacokinetic data supported
INX-189’s potential for once-daily dosing.
About Inhibitex
Inhibitex, Inc. is a clinical stage biopharmaceutical company
focused on developing products to prevent and treat serious
infectious diseases. In addition to INX-189, the Company’s clinical
stage pipeline includes FV-100, a bicyclic nucleoside inhibitor in
Phase II development for the treatment of shingles. 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 completing the
remaining monotherapy cohorts and evaluating the potential
antiviral synergies of INX-189 in combination with ribavirin in the
ongoing Phase 1b study; the Company reporting additional safety,
antiviral and pharmacokinetic data later this quarter; and the
potential of INX-189 as a potent, once-daily oral therapy amenable
to combination with other antivirals 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 of ongoing or future
preclinical or clinical studies of INX-189 not supporting its
further development for lack of safety, tolerability, antiviral
activity, or any other reason; INX-189 not demonstrating sufficient
anti-viral activity as monotherapy or any anti-viral synergies with
ribavirin in the Phase 1b trial as a once-daily dose; either the
Company, the FDA, a safety review 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.
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