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BI's Phase II Drug Could Be The First Second-Wave Protease Inhibitor For HCV

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

BOSTON - Competition is heating up in the hepatitis C space, not to be first to market with a small-molecule therapy but to produce a second-generation drug with a better dosing regimen and fewer side-effects than either of the two current frontrunners: Vertex Pharmaceuticals' telaprevir and Schering-Plough's boceprevir

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AASLD, In Brief

All STAT-C therapy still on track; looking forward to INFORM-2: Roche reported positive news from three final higher-dose cohorts of the INFORM-1 trial, a Phase I study of two direct-acting antiviral compounds administered orally to hepatitis C patients without standard-of-care interferon and ribavirin, at the American Association for the Study of Liver Disease meeting in Boston on Nov. 3. While it is early days, the effort is being followed closely for its potential to eliminate IFN/RBV and their side effects from the standard treatment regimen for HCV (1"The Pink Sheet," May 4, 2009). The investigational therapy combines InterMune's ritonavir-boosted protease inhibitor, ITMN-191/R7227, with the nucleoside polymerase inhibitor R7128, from Pharmasset. The Phase II INFORM-2 study will launch in the first quarter of 2010 to investigate twice-daily dosing of the STAT-C combination alone, in combination with interferon alfa-2a, with ribavirin, and with both. Longer term studies evaluating sustained virologic response - which is considered a cure in hep C - are planned for the first half of 2010

Vertex's Telaprevir Works In Twice Daily Dose; Response-Guided Therapy Cuts Down Drop-Outs

Is it a trick or a treat? AASLD lifts embargo on all annual meeting data at Halloween press conference.

INFORM-1 Data Show Potential Efficacy And Safety Of Roche HCV Combo

Combination therapy with two experimental, oral, direct-acting antivirals in treatment-naïve hepatitis C patients showed significant viral-load reductions and a clean safety profile, Roche and its biotech partners on the two drugs announced April 25 during the European Association for the Study of the Liver conference in Copenhagen, Denmark

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