InterMune, Inc.
(Nasdaq: ITMN) announced that it has begun dosing in its Phase 1b
clinical trial evaluating ITMN-191, designated R7227 at Roche (SWX: ROG),
in combination with Pegasys(R) (pegylated interferon alpha-2a) and
Copegus(R) (ribavirin) in treatment-naive patients infected with chronic
hepatitis C virus (HCV) genotype 1 infection.
InterMune also reported that results from the only cohort of
treatment-experienced patients in its Phase 1b multiple-ascending-dose
(MAD) clinical trial of ITMN-191 given as monotherapy support continued
development of the compound in treatment-experienced patients. InterMune
expects to submit results from all dose cohorts in the MAD study for
possible presentation at the Annual Meeting of the American Association for
the Study of Liver Diseases (AASLD).
Dan Welch, Chairman and Chief Executive Officer of InterMune, said,
"After having recently announced excellent safety and very competitive
reductions in serum HCV RNA levels following monotherapy of ITMN-191 in
treatment-naive chronic hepatitis C patients, we are pleased to announce
the start of our very important 14-day triple combination study of ITMN-191
plus Pegasys and ribavirin, also in treatment-naive patients." He
continued, "We are also pleased to report that ITMN-191 given as
monotherapy to treatment-experienced patients demonstrated a safety profile
and viral kinetic performance that support the continued development of
ITMN-191 in this patient population. Based on the monotherapy results to
date, we and our partner Roche are planning the development of ITMN-191 in
combination with various antiviral compounds, including other small
molecule direct antivirals, in both treatment-naive and
treatment-experienced patients."
Phase 1b Triple Combination Trial Design
The Phase 1b placebo-controlled, triple combination study is
anticipated to enroll up to approximately 50 treatment-naïve patients
chronically infected with HCV genotype 1. The study will assess the effects
of multiple doses and regimens of ITMN-191 given in combination with
pegylated interferon alpha-2a (Pegasys(R)) and ribavirin on safety,
efficacy, pharmacokinetics and viral kinetics compared to the effects in
patients treated only with pegylated interferon alpha-2a and ribavirin.
All patients will receive standard treatment with pegylated interferon
alfa-2a and ribavirin. In addition to this standard treatment, patients
will be randomized to receive either ITMN-191 or placebo, administered with
a meal for a period of 14 days, and a single dose on Study Day 15.
Up to five cohorts of patients will be enrolled, exploring total daily
doses starting at 300mg. Both twice daily and three-times-daily regimens
will be studied to collect data on the safety, pharmacokinetic and viral
kinetic effects of ITMN-191 when given with Pegasys and ribavirin.
InterMune expects to announce top-line results from the triple
combination study during the fourth quarter of this year.
Publication Plans for ITMN-191
InterMune intends to submit several abstracts regarding ITMN-191 for
possible presentation at the 59th Annual Meeting of the American
Association for the Study of Liver Diseases (AASLD), scheduled for October
31 - November 4, 2008 in San Francisco. Among the abstracts submitted will
be the clinical experience with ITMN-191 to date including, but not limited
to, the results of the single-ascending-dose (SAD) study, the
multiple-ascending-dose (MAD) monotherapy study of ITMN-191 as well as
in-vitro results of ITMN-191 in combination with various direct antiviral
compounds.
About InterMune
InterMune is a biotechnology company focused on the research,
development and commercialization of innovative therapies in pulmonology
and hepatology. InterMune has a pipeline portfolio addressing idiopathic
pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The
pulmonology portfolio includes the Phase 3 program, CAPACITY, which is
evaluating pirfenidone as a possible therapeutic candidate for the
treatment of patients with IPF and a research program focused on small
molecules for pulmonary disease. The hepatology portfolio includes the HCV
protease inhibitor compound ITMN-191 (referred to as R7227 at Roche) in
Phase 1b, a second-generation HCV protease inhibitor research program, and
a research program evaluating a new target in hepatology. For additional
information about InterMune and its R&D pipeline, please visit
intermune.
Forward Looking Statements
This news release contains forward-looking statements within the
meaning of section 21E of the Securities Exchange Act of 1934, as amended,
that reflect InterMune's judgment and involve risks and uncertainties as of
the date of this release, including without limitation the statements
related to anticipated product development timelines. All forward-looking
statements and other information included in this press release are based
on information available to InterMune as of the date hereof, and InterMune
assumes no obligation to update any such forward-looking statements or
information. InterMune's actual results could differ materially from those
described in InterMune's forward-looking statements.
Factors that could cause or contribute to such differences include, but
are not limited to, those discussed in detail under the heading "Risk
Factors" in InterMune's most recent annual report on Form 10-K filed with
the SEC on March 14, 2008 (the "Form 10-K") and other periodic reports
filed with the SEC, including the following: (i) risks related to the long,
expensive and uncertain clinical development and regulatory process,
including having no unexpected safety, toxicology, clinical or other issues
or delays in anticipated timing of the regulatory approval process; (ii)
risks related to failure to achieve the clinical trial results required to
commercialize our product candidates; and (iii) risks related to timely
patient enrollment and retention in clinical trials. The risks and other
factors discussed above should be considered only in connection with the
fully discussed risks and other factors discussed in detail in the Form
10-K and InterMune's other periodic reports filed with the SEC, all of
which are available via InterMune's web site at intermune.
Pegasys(R) and Copegus(R) are registered trademarks of Roche
InterMune, Inc.
intermune
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