ARTICLE | Clinical News

Telaprevir meets REALIZE endpoint

September 8, 2010 12:42 AM UTC

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) said telaprevir plus standard of care (SOC) met the primary endpoint vs. SOC alone in the Phase III REALIZE trial to treat HCV genotype 1 infection in patients who failed previous therapy. Simultaneous start- and delayed start-telaprevir regimens plus SOC led to a significantly greater proportion of patients achieving a sustained virologic response (SVR) 24 weeks after the end of treatment vs. SOC alone (64% and 66%, respectively, vs. 17%). The double-blind trial enrolled 662 patients. SOC consisted of Pegasys peginterferon alfa-2a and Copegus ribavirin, both of which are marketed by Roche (SIX:ROG; OTCQX:RHHBY).

In July, Vertex began submission of a rolling NDA to FDA for the small molecule HCV NS3/4A protease inhibitor. The company plans to complete the submission in 4Q10. REALIZE is the third of three trials in a Phase III program for telaprevir in HCV. Vertex reported data from the ADVANCE and ILLUMINATE trials in May and August, respectively. ...