- 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.
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.
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.
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.|
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