BRISBANE, Calif., April 14 /PRNewswire-FirstCall/ -- InterMune, Inc. today announced top-line results from the planned Week 12 interim analysis of the Phase 2b randomized, partially-blind study evaluating the hepatitis C virus (HCV) protease inhibitor danoprevir (also known as RG7227 and ITMN-191), administered for 12 weeks in combination with PEGASYS(R) (pegylated interferon alfa-2a) and COPEGUS(R) (ribavirin), compared with placebo for the same duration plus PEGASYS and COPEGUS. The virologic response results are summarized in the following table:
Frank Duff, M.D., Head of Roche's Clinical Development for Virology, said, "Future development of danoprevir is expected to be conducted in combination with ritonavir at total daily doses that are 10-25% of those examined in this study. The pharmacokinetics/pharmacodynamics and safety data from this large, well-controlled study, in addition to other data being collected, will be very helpful in our efforts to choose the optimal dose and regimen for the ritonavir-boosted danoprevir global development program, including the all-oral, direct-acting antiviral INFORM component of the program."
About the Study
The Phase 2b triple combination study, conducted at 45 sites globally, was designed to define the safety and efficacy profile of danoprevir for a treatment duration of 12 weeks as part of a total treatment duration of 24 or 48 weeks. The study was conducted by Roche as part of its collaboration with InterMune for the development of protease inhibitors. 232 patients were randomized to one of four treatment groups - three of which received a 12-week regimen of danoprevir at either 300 mg three times daily, 600 mg twice daily or 900 mg twice daily, in combination with PEGASYS and COPEGUS, followed by 12 or 36 weeks of therapy with PEGASYS and COPEGUS for a total of 24 or 48 weeks. The fourth group was a control arm receiving PEGASYS and COPEGUS for 48 weeks. In November of 2009, InterMune reported that due to a safety signal, dosing in the 900 mg group had been stopped. Patients already receiving treatment in this group continued on PEGASYS and COPEGUS. A total of 13 patients who were originally randomized to this group but had not received the study drug were later re-randomized to the other dose groups and are not included in the efficacy analysis. A total of 212 patients were included in the efficacy analysis population.
Other Studies with Danoprevir
InterMune announced in January 2010 that based upon promising preliminary results from a Phase 1b multiple-ascending-dose (MAD) study of ritonavir-boosted danoprevir, the full results of which are to be presented on April 15 at EASL, that the further development of danoprevir was expected to be in combination with low-dose ritonavir. The companies have amended the on-going Phase 1b MAD 15-day ritonavir-boosting study to evaluate 12 weeks of low doses of ritonavir-boosted danoprevir plus SOC, PEGASYS and COPEGUS, in prior SOC null responders. In addition, the companies plan to launch a Phase 2b study of ritonavir-boosted danoprevir plus SOC, PEGASYS and COPEGUS in late Q3 or early Q4 of 2010.
About Danoprevir (RG7227/ITMN-191)
Danoprevir (also known as RG7227 and ITMN-191) is a potent, macrocyclic inhibitor of HCV NS3/4A protease activity, and has produced multi-log(10) reductions in levels of HCV in chronic HCV patients, when administered for 14 days as monotherapy and when combined with PEGASYS(R) (peginterferon alfa-2a) and COPEGUS(R) (ribavirin, USP). Danoprevir was safe and well-tolerated in these studies.
This news release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect InterMune's judgment and involve risks and uncertainties as of the date of this release, including without limitation the statements related to anticipated product development timelines, the dates on which clinical data will be released and intended changes to certain of InterMune's clinical studies. All forward-looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward-looking statements.
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