INTERMUNE INITIATES TRIAL OF HEPATITIS C PROTEASE INHIBITOR

InterMune and its partner Roche have received approval of the European Clinical Trial Authorization to begin a study of ITMN-191, the NS3/4A protease inhibitor. They have initiated a Phase Ia clinical trial evaluating ITMN-191 for the treatment of chronic hepatitis C virus infection. The trial will assess safety, tolerability, pharmacokinetics and food affect in a double-blind, placebo-controlled, single-ascending-dose study. The study is being conducted at one clinical trial site in Europe and will enroll approximately 74 healthy volunteers. InterMune expects to dose the first patient with ITMN-191 in early January.

Preclinical data indicates ITMN-191 has the potential to be an important addition to therapy for hepatitis C patients because of its favorable cross resistance and potency profiles, as well as pharmacokinetic results that support the exploration of twice-daily oral dosing in future clinical trials, according to InterMune.

Currently available therapies to treat hepatitis C are insufficient, creating a need for the development of novel therapeutic approaches, according to InterMune. The hepatitis C NS3/4A protease is an attractive drug target because of its potential involvement in viral replication and suppressive effects on host response to viral infection. Inhibitors of the hepatitis C protease, such as ITMN-191, represent a promising new class of drugs for hepatitis C.