Inhibitex Commences Dosing of Phase 2 Clinical Trial of INX-189 in HCV Infected Genotype 2/3 Patients
September 19 2011 - 7:05AM
Business Wire
Inhibitex, Inc. (Nasdaq: INHX), announced today that it has
recently commenced dosing in a 90-patient randomized, placebo
controlled, treatment guided, Phase 2 clinical trial to evaluate
the safety, tolerability and antiviral activity of INX-189 in
combination with pegylated interferon and ribavirin in chronic
HCV-infected genotype 2 and 3 treatment naïve patients. The trial
is designed to evaluate three once-daily doses of INX-189 (25 mg,
50 mg and 100 mg) administered in combination with pegylated
interferon and ribavirin for 12 weeks, and also includes a control
arm in which patients will receive placebo and standard of care
treatment (a combination of pegylated interferon and ribavirin for
24 weeks). Each INX-189 combination treatment cohort in the trial
will include 25 patients, and the control arm will include 15
patients.
Patients in the INX-189 containing treatment arms that achieve
an extended rapid viral response, or eRVR, defined as having HCV
RNA below the level of detection after 28 days and 12 weeks of
dosing, will stop all therapy after 12 weeks. Those patients who do
not achieve an eRVR will continue receiving pegylated interferon
and ribavirin for 12 additional weeks.
The Company also announced the initiation of an additional
clinical trial of INX-189 designed to evaluate higher doses of
INX-189 administered as monotherapy or in combination with
ribavirin for seven days. The first cohort in this expanded Phase
1b trial will receive 200 mg INX-189 once daily as monotherapy.
Other planned cohorts include 100 mg INX-189 twice daily as
monotherapy, 100 mg INX-189 once daily in combination with
ribavirin, and possibly higher monotherapy doses of INX-189. Each
treatment cohort in the trial will include 10 patients, eight of
which will receive INX-189 and two of which will receive
placebo.
About HCV and INX-189
Hepatitis C is a disease of the liver caused by the hepatitis C
virus (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-methyl guanosine 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. The Company’s clinical-stage pipeline currently includes
two Phase 2 development programs; INX-189, a nucleotide polymerase
inhibitor in development for the treatment of chronic hepatitis C
infections and FV-100, a nucleoside analogue in development for the
treatment of shingles-associated pain. The Company also has other
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 number of patients the Company
expects to enroll in the ongoing Phase 2 trial and the planned
cohorts, and possibly including higher monotherapy doses of
INX-189, in the ongoing supplementary Phase 1b trial, and the
Company’s belief 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, 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, an institutional review board (IRB), 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 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 Reports on Form 10-Q for
the quarters ended March 31 and June 30, 2011. 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)
Historical Stock Chart
From Jun 2024 to Jul 2024
Inhibitex, Inc. (MM) (NASDAQ:INHX)
Historical Stock Chart
From Jul 2023 to Jul 2024