InterMune Announces Continuing Progress on ITMN-191 (R7227)
- Principal Goals of Phase 1b MAD Trial Already Achieved - - Advancing to Triple Combination Trial -
BRISBANE, Calif., Jan 07, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- InterMune, Inc. (Nasdaq: ITMN) today provided an update on the progress of its Phase 1b multiple-ascending-dose (MAD) clinical trial evaluating ITMN-191 (R7227) as monotherapy in patients with chronic hepatitis C virus (HCV) infection. ITMN-191 is an HCV protease inhibitor in development by InterMune and its partner, Roche.
Dan Welch, President and Chief Executive Officer of InterMune, said, "We have now completed our first two dosage cohorts in the MAD study, with total daily doses of up to 300mg, and expect the third dosage cohort to be enrolled in January. We are very pleased to announce that after completing the first two low-dosage cohorts, we have already achieved the principal goals of the MAD study for viral kinetic performance, safety and tolerability and are now advancing the program to study ITMN-191 in combination with Pegasys(R) and ribavirin. In view of the very favorable safety profile observed to date, we will continue dose escalation in the MAD trial to a third and possibly fourth cohort in order to more fully evaluate the viral kinetic profile, safety and tolerability of higher doses of ITMN-191. In parallel with the conduct of the ongoing MAD study, we are preparing and will submit to the appropriate European authorities the clinical trial authorization application to gain approval to begin a 14-day triple combination study of ITMN-191 with Pegasys(R) and ribavirin in the second quarter."
The company also announced that it is on track to announce top-line viral kinetic and safety results from at least three treatment-naÃ¯ve dose cohorts of the ongoing MAD clinical study later in the first quarter of this year. InterMune also expects to submit full data from all available cohorts of the current Phase 1b study for possible presentation at one or more scientific conferences in the second quarter of 2008.
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. The principal goal of the MAD study is to help choose the dose of ITMN-191 that when administered in combination with Pegasys(R) and ribavirin, would likely offer the most competitive protease inhibitor-based triple combination regimen in terms of efficacy, safety and tolerability.
In the Phase 1b study, three or four cohorts of treatment-naive patients receive ITMN-191 twice per day (BID) or three times per day (TID) 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 be studied once the treatment-naive cohorts are completed.
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.
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 30, 2007 (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 http://www.intermune.com.Â