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
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