BRISBANE,
Calif., April 1, 2008 -- InterMune, Inc. (Nasdaq: ITMN) today provided an overall
program update and reported the top-line results from the four dose cohorts of
treatment-naive patients in its ongoing Phase 1b clinical trial of ITMN-191, designated
R7227 at Roche. ITMN-191 was administered as monotherapy in patients with chronic
hepatitis C virus (HCV) genotype 1 infection. InterMune reported that treatment
with ITMN-191 resulted in rapid and significant reductions in HCV RNA (see table
below).
One
final cohort consisting of treatment-experienced patients dosed at 300 mg every
12 hours will begin dosing next week.
InterMune additionally reported that,
based on a preliminary review of the available and still blinded clinical data
from the four completed cohorts of the Phase 1b study, ITMN-191 was safe and well-tolerated.
No serious adverse events were reported and no subject discontinued the study
due to an adverse event. Adverse events were generally mild and transient in nature.
"With
rapid and substantial anti-viral effect at twice daily doses and an excellent
safety and tolerability profile to date, ITMN-191 has the potential to be the
best-in-class protease inhibitor for the treatment of patients with chronic hepatitis
C virus infection," said Dan Welch, President and Chief Executive Officer
of InterMune. "Strong viral kinetic performance of ITMN-191 was observed
at total daily doses of less than or equal to only 600 mg, confirming its exceptional
potency."
Mr. Welch continued, "With our partner Roche, we plan
to initiate in this quarter a 14-day triple combination therapy trial with Pegasys
(pegylated interferon alfa-2a) and Copegus (ribavirin). We also are exploring
the combination of ITMN-191 with other small molecule compounds."
ITMN-191
Program Update - Clinical, Preclinical, and Formulation Progress
InterMune
also provided additional new information regarding the progress of the ITMN-191
program.
InterMune today reported that Clinical Trial Authorization (CTA)
applications related to its 14-day triple combination study of ITMN-191 with Pegasys
(pegylated interferon alfa-2a) and Copegus (ribavirin) were submitted to the
relevant European regulatory authorities in March. InterMune expects the 14-day
triple combination study to begin in the second quarter of 2008, assuming timely
approvals by the relevant authorities.
Regarding future clinical development
approaches, InterMune and its collaboration partner Roche also reported that the
companies are actively working together to launch a development program that will
investigate the combination of various small molecule compounds for the treatment
of patients suffering from chronic HCV infection.
InterMune also announced
today that a 13-week chronic toxicology study in monkeys has been successfully
completed and that this study supports the intended longer duration of dosing
of ITMN-191 planned in the Phase 2 clinical development program, to be conducted
by Roche.
Regarding
formulation, InterMune reported that Roche has completed development of the tablet
formulation of ITMN-191 that will be used in the Phase 2 program. Given the relatively
low total daily dose of ITMN-191 required to show substantial antiviral activity,
Roche has begun work on a modified-release formulation of ITMN-191 with the goal
of optimizing the delivery of ITMN-191, potentially to a once per day administration.
Phase
1b (MAD) Trial Design
The ongoing Phase 1b placebo-controlled
study is designed to assess the effect of multiple doses of ITMN-191 given as
monotherapy on viral kinetics, viral resistance, pharmacokinetics, safety and
tolerability. A principal goal of the MAD study is to help choose the range of
doses of ITMN-191 that when administered in combination with Pegasys
(pegylated interferon alfa-2a) and Copegus (ribavirin) would likely offer
the optimal protease inhibitor-based triple combination regimen in terms of efficacy,
safety and tolerability. The Phase 1b study also will inform the design of future
combination studies using small molecule HCV compounds of different mechanisms
of action.
In the Phase 1b study, four cohorts of treatment-naïve
patients received ITMN-191 in a gelatin capsule every 12 hours or every 8 hours
with food for a period of 14 days. In addition, a single cohort of treatment-experienced
chronic hepatitis C patients infected with HCV genotype 1 will begin dosing next
week at the 300mg every 12 hour dose level.
About
InterMune
InterMune is a biotechnology company focused on
the research, development and commercialization of innovative therapies in pulmonology
and hepatology. InterMune has a research and development 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 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 http://www.intermune.com.
For
more information, visit InterMune's web site at www.intermune.com.
4/04/08
Source
InterMune,
Inc. InterMune Announces Top-Line Results of Phase 1b Trial of ITMN-191 (R7227)
and Provides Program Update. Press release. April 1, 2008.
