InterMune starts early trial of hepatitis C drug

ITMN-191 is a hepatitis C virus protease inhibitor in development by InterMune and its partner, Roche. The study will assess the effect of multiple doses of ITMN-191 given as a monotherapy on viral kinetics, viral resistance, pharmacokinetics, safety and tolerability.

The Phase Ib placebo-controlled study is anticipated to enroll approximately 40 HCV patients. Patients will be administered ITMN-191 twice per day (BID) or three-times per day (TID) with a meal for a period of 14 days. Three ascending dose cohorts of treatment-naive chronic hepatitis C patients infected with HCV genotype 1 will be enrolled. In addition, a single cohort of treatment-experienced chronic hepatitis C patients infected with HCV genotype 1 will be studied.

InterMune also reported additional information from its recently completed Phase Ia clinical trial of ITMN-191. This placebo-controlled study of ITMN-191 was completed in May of 2007, enrolling a total of 64 healthy volunteers. Doses in this study ranged from less than 10% to many-fold higher than those that will be evaluated in the three dosage cohorts of the Phase Ib trial.

The study results show that ITMN-191 was well tolerated in all doses evaluated. No serious adverse events (SAEs) were reported and no subject discontinued the study due to an adverse event (AE). All AEs in subjects receiving ITMN-191 were classified as mild (CTCAE Grade 1). The most common AEs reported were gastrointestinal-related and consisted of mild diarrhea and mild abdominal pain. These mild AEs occurred predominantly in the highest dose group, a dose many-fold higher than the doses planned in the Phase Ib study just begun.