InterMune, Inc. (Nasdaq: ITMN) today announced results of all three cohorts from a 15-day Phase 1b multiple-ascending-dose (MAD) study of low doses of danoprevir (also known as RG7227 and ITMN-191) boosted by low-dose ritonavir (RTV) in patients chronically infected with hepatitis C virus (HCV) genotype-1. The results announced today were reported in an oral presentation at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria by Edward Gane, M.D., Associate Professor, University of Auckland, and Director, Auckland Clinical Studies Limited.
Dr. Gane commented, "The results from this study indicate that robust viral kinetics in treatment- naive patients can be achieved by ritonavir boosting of very low doses of danoprevir. We look forward to the results of the two 12-week cohorts in prior SOC null responders recently added to this study which will provide further insights into the antiviral efficacy and safety profile of low doses of ritonavir-boosted danoprevir."
Dan Welch, Chairman and CEO of InterMune commented, "Importantly, 18 of 25 patients (72%) treated with ritonavir-boosted danoprevir had HCV RNA levels below the limit of detection after only 15 days in this study. These results are at least as strong as those of the 14-day observation period of the 12 week Phase 2b study using un-boosted, high doses of danoprevir with exposure substantially higher than ritonavir-boosted doses. The potential impact of lower systemic exposure on the long-term safety profile of danoprevir will be further evaluated in future studies. The collective results to date appear to confirm that our objective with ritonavir-boosting is realistic."
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