InterMune gets go ahead for Ph Ib HCV drug trial
US drugmaker InterMune says that the amended clinical trial authorization for a Phase Ib trial of ITMN-191 has been approved by the European regulator. The firm has also received approval from the ethics committees of the institutions that will conduct the study. The agent is an orally-available hepatitis C virus protease inhibitor in development with InterMune's partner, Swiss drug major Roche.
InterMune expects that the Phase 1b multiple ascending-dose study will begin this month and hopes to announce initial top-line viral kinetic and safety results from the first three dose cohorts of the MAD study in the first quarter of 2008.
Dan Welch, chief executive of InterMune, said: "by amending the Phase Ib protocol, we believe we have enhanced our ability to deliver the most robust Phase Ib results possible, which we expect will place us in a stronger position to begin our Phase II trials."
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