Vertex reports telaprevir data

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) reported data from the Phase III ILLUMINATE trial to treat HCV genotype 1 infection in treatment-naive patients. A 24-week telaprevir-based regimen was non-inferior to a 48-week regimen on the primary endpoint of the proportion of patients achieving a sustained virologic response (SVR) 24 weeks after the end of treatment (92% vs. 88%). The open-label, international trial enrolled 540 patients. Data will be presented at the American Association for the Study of Liver Diseases meeting in Boston in October. Last month, Vertex began submission of a rolling NDA to FDA for telaprevir to treat HCV. The company plans to complete the submission in 4Q10. Telaprevir is a small molecule HCV NS3/4A protease inhibitor.

ILLUMINATE is the second of three trials in a Phase III program for telaprevir in HCV. The third, REALIZE, is expected to report top-line data in September. Vertex reported data from the ADVANCE trial in May. ...