Roche Initiates Dosing In Phase 1b MAD Study

InterMune has announced that its partner Roche has begun dosing in a phase 1b multiple ascending dose (MAD) study of ITMN-191 (RG7227) boosted by low-dose ritonavir in patients chronically infected with hepatitis C virus (HCV) genotype-1.

InterMune announced on August 6, 2009, ITMN-191 showed high promise in a phase 1 single ascending dose (SAD) study in healthy volunteers. Important PK parameters showed marked improvement and increases in AUC and drug concentrations were observed.

The MAD study is to determine the pharmacokinetic (PK), viral kinetic and safety profiles of ascending doses of once-daily and twice-daily ITMN-191 co-administered with low doses of ritonavir and standard dose Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in HCV-infected patients and for 14 days. On August 6, the company has announced results of a phase 1 study of ITMN-191 co-administered with low dose ritonavir in healthy volunteers.

ITMN-191/RG7227 is a potent, macrocyclic inhibitor of HCV NS3/4A protease activity currently in phase 2b development and is being developed in collaboration with Roche. The safety and antiviral activity of ITMN-191 is under clinical investigation in combination with the NS5B nucleoside inhibitor RG7128 in the INFORM clinical development program.

Dan Welch, chairman, president and CEO of InterMune, said: “We and our partner Roche are very pleased by the performance of ITMN-191 in twice-daily regimens when un-boosted with ritonavir. However, if results of ritonavir boosting of ITMN-191 in human volunteers are replicated in this study of HCV patients, the approach could lead to achieving more sustained exposures with lower twice-daily doses of ITMN-191 or perhaps allow once-daily administration. Either of these two possibilities could provide patients a regimen with more convenient administration and with the clinical advantages associated with sustained drug exposure.”