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InterMune Announces Top-Line Results of Phase 1b Trial of ITMN-191 (R7227) and Provides Program Update
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* Rapid and significant reductions in HCV RNA observed; well tolerated in all dose cohorts
* Significant progress made in clinical, preclinical and formulation
BRISBANE, Calif., April 1, 2008 /PRNewswire-FirstCall/ -- 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 (SWX: ROG). 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 300mg 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(R) (pegylated interferon alfa-2a) and Copegus(R) (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(R) (pegylated interferon alfa-2a) and Copegus(R) (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(R) (pegylated interferon alfa-2a) and Copegus(R) (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-naive 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.
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