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InterMune Reports Results from Triple Combination Study of ITMN-191

(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

SOURCE InterMune, Inc.
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