Advertisement
Dan Welch, President and Chief Executive Officer of InterMune, said, "Weare pleased to have successfully initiated the very important Phase 1bmultiple ascending dose study of ITMN-191." Mr. Welch continued, "This is ourfirst opportunity to evaluate the effects of ITMN-191 on viral kinetics in HCVpatients, and to gather additional safety information beyond the recentlycompleted Phase 1a SAD study. We look forward to sharing top-line resultsfrom the three treatment-naïve dose cohorts of the Phase 1b study in the firstquarter of 2008."
Advertisement
Phase 1b Trial Design
The Phase 1b placebo-controlled study is anticipated to enrollapproximately 40 HCV patients. The study will assess the effect of multipledoses of ITMN-191 given as a monotherapy on viral kinetics, viral resistance,pharmacokinetics, safety and tolerability. Patients will be administeredITMN-191 twice per day (BID) or three-times per day (TID) with a meal for aperiod of 14 days. Three ascending dose cohorts of treatment-naive chronichepatitis C patients infected with HCV genotype 1 will be enrolled. Inaddition, a single cohort of treatment-experienced chronic hepatitis Cpatients infected with HCV genotype 1 will be studied. If the results of thefirst three dosage cohorts indicate that more information would be desirableto more fully inform the design of a planned study of ITMN-191 in combinationwith Pegasys(R) and ribavirin, the Phase 1b study will be expanded to includeadditional cohorts of treatment-naive patients.
Further Details on Phase 1a Study -- Safety and Pharmacokinetic Profile ofITMN-191
The Phase 1a placebo-controlled study of ITMN-191 was completed in May of2007, enrolling a total of 64 healthy volunteers. Doses in this study rangedfrom less than 10% to many-fold higher than those that will be evaluated inthe three dosage cohorts of the Phase 1b trial. The study results show that:
About InterMune
InterMune is a biotechnology company focused on the research, developmentand 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 portfolioincludes the Phase 3 program, CAPACITY, which is evaluating pirfenidone as apossible therapeutic candidate for the treatment of patients with IPF and aresearch program focused on small molecules for pulmonary disease. Thehepatology portfolio includes the HCV protease inhibitor compound ITMN-191(referred to as R7227 at Roche) in Phase 1a, a second-generation HCV proteaseinhibitor research program, and a research program evaluating a new target inhepatology. For additional information about InterMune and its R&D pipeline,please visit http://www.intermune.com.
Forward-Looking Statements
This news release contains forward-looking statements within the meaningof section 21E of the Securities Exchange Act of 1934, as amended, thatreflect InterMune's judgment and involve risks and uncertainties as of thedate of this release, including without limitation the statements related toanticipated product development timelines. All forward-looking statements andother information included in this press release are based on informationavailable to InterMune as of the date hereof, and InterMune assumes noobligation to update any such forward-looking statements or information.InterMune's
