Recently, InterMune (ITMN) announced results from a mid-stage study of one of its pipeline candidates, danoprevir. The drug is being studied in a phase IIb trial to treat hepatitis C. The study was conducted by Roche (RHHBY) as part of its collaboration with InterMune for the development of protease inhibitors.
The phase IIb trial was looking to evaluate the safety and effectiveness of danoprevir in combination with PEGASYS (pegylated interferon alfa-2a) and COPEGUS (ribavirin) compared to placebo in combination with PEGASYS and COPEGUS. The trial was conducted with 232 patients for 12 weeks.
Patients in the trial were randomized to receive danoprevir in various dosages — 300 mg three times daily, 600 mg twice daily or 900 mg twice daily. However, in Nov. 2009, the dosage of 900 mg was stopped due to some safety issues.
Similar virologic response was observed in all the dosage forms of danoprevir throughout the 12 weeks of treatment and thereafter. Viral response of patients receiving the highest dose of the drug was not meaningfully different from patients receiving 600 mg twice daily or 300 mg thrice daily.
According to InterMune, analysis of the safety data is in its initial stages, which continues to undergo further evaluation. However, preliminary analyses have shown that serious adverse events were generally balanced across all the treatment groups.
InterMune is also conducting other studies with danoprevir. In Jan. 2010, the company came out with positive results from a phase Ib study of ritonavir-boosted danoprevir, full results of which are expected shortly. The 15-day study is looking to evaluate the impact of ritonavir-boosted danoprevir (in low dosage) in addition to ‘standard of care’ (SOC), PEGASYS and COPEGUS, in patients who did not respond positively to SOC earlier.
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