InterMune to Begin ITMN-191 Trial
InterMune announced that the amended clinical trial authorization related to the Phase Ib clinical trial of ITMN-191, a treatment of hepatitis C virus (HCV), has been approved by European regulatory authorities.
ITMN-191 (Roche-R7227) is an orally available HCV protease inhibitor in development by InterMune and its partner, Roche.
InterMune said it expects that the Phase Ib multiple ascending dose study will begin this month, and initial topline viral kinetic and safety results from the first three dose cohorts will be available in the first quarter of 2008.
The Phase Ib study is designed to assess the effect on viral kinetics, viral resistance, pharmacokinetics, safety and tolerability of multiple ascending doses of ITMN-191 given as a monotherapy.