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news.Vertex Pharmaceuticals has reported that it will begin Phase III evaluation of telaprevir, the company's lead investigational hepatitis C protease inhibitor.
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The primary focus will be a global, three-arm pivotal controlled trial that will evaluate two 24-week telaprevir-based regimens in approximately 1050 treatment-naive genotype 1 hepatitis C virus (HCV) patients. In this study, rapid viral response (RVR) criteria will be used to determine which telaprevir patients can stop all treatment at 24 weeks.
Vertex has agreed to conduct a second well-controlled clinical study as part of the registration program for a treatment-naive indication. The objective of this second study would be to develop additional sustained viral response (SVR) and relapse rate data of 400-500 HCV patients with 48-weeks treatment duration that confirm results from the Phase II studies, thereby providing additional evidence supporting the 24-week regimen in the Phase III trial. The company expects that both studies will run concurrently and that the first trial will begin enrolling patients in March 2008.
The primary objective of the two studies will be to assess the proportion of patients in each study arm who achieve SVR, defined as undetectable (less than 10 IU/mL, as measured by the Roche TaqMan assay) HCV RNA 24 weeks after the completion of dosing. Vertex expects to have SVR data from both studies by mid-2010.