InterMune Reports Results from Triple Combination Study of ITMN-191
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- Q12h and Q8h Regimens Deliver Robust Antiviral Effects and Strong Safety
Profile -
- Phase2b Study Anticipated to Begin in Q2 2009 -
- Conference call today at 8:30 a.m. EST -
BRISBANE, Calif., Jan. 12 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq:
ITMN) today reported top-line results from all six completed dosage cohorts of
its Phase 1b clinical trial of ITMN-191 (R7227) in combination with
standard-of-care Pegasys(R) (peginterferon alfa-2a) and Copegus(R) (ribavirin)
for 14 days of treatment in hepatitis C virus (HCV) treatment-naive patients
infected with HCV genotype 1. ITMN-191 is being developed in collaboration
with Roche (SWX: ROG). Viral kinetic performance and safety results were
reported for three cohorts each of ITMN-191 given every 12 hours (q12h) and
every eight hours (q8h).
Viral Kinetic Performance
After 14 days of triple combination therapy, the median change in HCV RNA from
baseline exceeded 5 logs in five of the six cohorts and was -5.4 log and -5.7
log in the best performing q12h and q8h cohorts, respectively. Considering
all cohorts, HCV RNA was below the limit of quantification in nearly
three-quarters (71%, or 32 of 45) of patients who received treatment with
ITMN-191 after only 14 days of treatment. In all q12h and q8h cohorts,
reductions in HCV RNA occurred rapidly and there was no evidence of viral
rebound during ITMN-191 treatment.
Safety and Tolerability Profile
ITMN-191 was generally safe and well tolerated. There were no serious adverse
events (SAE) or Grade 4 adverse events (AEs) during treatment with ITMN-191.
AEs reported during study treatment (ITMN-191 or placebo) were predominantly
mild to moderate in severity, typically consistent with the well-described AE
profile of standard of care (SOC) and none led to treatment discontinuation.
Only four Grade 3 AEs were reported during study treatment, two of which
(sciatica and back pain) were deemed by the investigator to be unrelated to
ITMN-191. The other two were neutropenia and indirect bilirubin elevation.
Neutropenia occurred with a similar pattern, frequency and severity in the
placebo and ITMN-191 groups. Minor and transient elevations in indirect
bilirubin levels were observed in a small number of placebo and ITMN-191
patients and were deemed not clinically significant by the investigator.
There were no other laboratory or ECG findings during study treatment that
were attributable to ITMN-191.
Summary of Viral Kinetic Assessments Following 14 Days of Treatment
Median Change
HCV RNA at
EOT(1),(2) BLQ BLD
Log10 (<25 IU/mL) (<9.3 IU/mL)
Dose N (IU/mL) (%) (%)
Placebo 12 -2.2 1/12 (8%) 0/12 (0%)
100 mg q8h 8 -5.5 6/8 (75%) 1/8 (13%)
200 mg q8h 8 -5.7 7/8 (88%) 4/8 (50%)
300 mg q8h 7 -5.6 5/7 (71%) 4/7 (57%)
400 mg q12h 7 -4.7 4/7 (57%) 1/7 (14%)
600 mg q12h 8 -5.4 6/8 (75%) 1/8 (13%)
900 mg q12h 7 -5.3 4/7 (57%) 1/7 (14%)
(1) EOT = End of Treatment
(2) Values below Limit of Quantification (LOQ) of 25 IU/mL were
assigned value of 1.236 log10; values below Limit of Detection
(LOD) of 9.3 IU/mL were assigned value of 0.667 log10
A chart of the median log10 HCV RNA changes from baseline to Day 14 for each
dose cohort is available on the investor relations page of InterMune's
corporate website at www.intermune.com.
Dr. Stefan Zeuzem, Professor of Medicine, Chief of the Department of Medicine
at the J.W. Goethe University Hospital in Frankfurt, Germany and protocol
chair of this study said, "Based on the totality of the viral kinetic data, in
particular BLQ, a robust predictor of virologic outcome, the q12h and q8h
regimens delivered very convincing viral kinetic results and appeared to
perform very comparably in this 14-day study. The safety and tolerability
profile of ITMN-191 in both the earlier monotherapy study and in the present
triple combination study was also encouraging, as no issues of concern were
observed. We look forward to the completion of the planned Phase 2b study to
determine if the very promising profile of ITMN-191 observed will be
confirmed."
Dan Welch, Chairman, Chief Executive Officer and President of InterMune said,
"We are very pleased to report that in this 14-day study, both the q12h and
q8h regimens of ITMN-191 delivered viral kinetic performance that we believe
is very competitive with that reported to date for other protease inhibitors
in similar experiments. In addition, the strong safety and tolerability
profile of ITMN-191 observed in prior Phase 1 experiments was reinforced in
this study, even in the presence of standard-of-care therapy and at doses
significantly higher than those used in monotherapy." Mr. Welch continued,
"We believe that the viral kinetic and safety results reported today provide
evidence that ITMN-191 has the potential to deliver superior sustained
virologic response (SVR) rates on an intent-to-treat basis. In pursuit of
this goal, our Phase 2b study, anticipated to begin in the second quarter of
2009, will study both q12h and q8h regimens and both 12 and 24-week treatment
durations."
Phase 1b Triple Combination Trial Design
The Phase 1b randomized, double-blind, placebo-controlled, 14-day triple
combination study in treatment-naive patients chronically infected with HCV
genotype 1 was designed to inform the dose selection and study design of the
ITMN-191 Phase 2 program. The study objectives were to assess the safety,
pharmacokinetic and viral kinetic effects of various doses and regimens of
ITMN-191 for 14 days in combination with Pegasys and Copegus compared to
treatment with Pegasys and Copegus alone. Patient follow-up continues for 30
days following the completion of study treatment.
INFORM-1 Progress (All-oral STAT-C study)
In November 2008, Roche, InterMune and Pharmasset initiated the first all-oral
combination study of direct anti-virals in the absence of interferon or
ribavirin, known as the INFORM-1 study. That study has completed the first
dose cohort. Results of INFORM-1 are expected to be reported at a major
medical conference in the second quarter of this year.
Conference Call and Webcast Details
InterMune will host a conference call today at 8:30 a.m. EST to discuss the
results of the 14-day triple combination study of ITMN-191. Interested
investors and others may participate in the conference call by dialing
888-799-0528 (U.S.) or 973-200-3372 (international), conference ID# 80676348.
A replay of the webcast and teleconference will be available approximately
three hours after the call.
To access the webcast, please log on to the company's website at
www.intermune.com at least 15 minutes prior to the start of the call to ensure
adequate time for any software downloads that may be required.
The teleconference replay will be available for 10 business days following the
call and can be accessed by dialing 800-642-1687 (U.S.) or 706-645-9291
(international), and entering the conference ID# 80676348.
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 new targets in
hepatology. For additional information about InterMune and its R&D pipeline,
please visit www.intermune.com.
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 www.intermune.com.
Pegasys(R) and Copegus(R) are registered trademarks of Roche.
SOURCE InterMune, Inc.
Jim Goff of InterMune, Inc., +1-415-466-2228, jgoff@intermune.com
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