InterMune Announces Positive Results of Phase Ib HCV Trial
Posted on: Thursday, 3 April 2008, 12:01 CDT
InterMune has reported the positive top-line results from the four dose cohorts of treatment-naive patients in its ongoing Phase Ib clinical trial of ITMN-191, designated R7227 at Roche.
ITMN-191 was administered as monotherapy in patients with chronic hepatitis C virus (HCV) genotype 1 infection. InterMune reported that treatment with ITMN-191 resulted in rapid and significant reductions in HCV RNA. Based on a preliminary review of the available and still blinded clinical data from the four completed cohorts of the Phase Ib study, ITMN-191 was found to be safe and well-tolerated. One final cohort consisting of treatment-experienced patients dosed at 300mg every 12 hours will begin dosing next week.
InterMune has reported that clinical trial authorization applications related to its 14-day triple combination study of ITMN-191 with Pegasys (pegylated interferon alfa-2a) and Copegus (ribavirin) were submitted to the relevant European regulatory authorities in March, 2008.
InterMune also successfully completed a 13-week chronic toxicology study in monkeys, which supports the intended longer duration of dosing of ITMN-191 planned in the Phase II clinical development program, to be conducted by Roche. Roche has completed development of the tablet formulation of ITMN-191 that will be used in the Phase II program.
Dan Welch, president and CEO of InterMune, said: "With our partner Roche, we plan to initiate in this quarter a 14-day triple combination therapy trial with Pegasys and Copegus. We also are exploring the combination of ITMN-191 with other small molecule compounds."
Source: Datamonitor
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