S-P to initiate Ph III boceprevir program

US drug major Schering-Plough has announced plans to initiate two large-scale Phase III studies of its investigational oral hepatitis C protease inhibitor boceprevir in chronically-infected genotype-1 HCV.

One trial will be in previously-untreated patients and the other in people who failed prior treatment (relapsers and non-responders), an area of great unmet medical need, noted the Kenilworth, New Jersey-based company. Both randomized, double-blind, placebo-controlled studies will evaluate boceprevir in combination with Pegintron (peginterferon alfa-2b) and Rebetol (ribavirin, USP) compared these two drugs alone. The two pivotal studies will run concurrently and will enroll more than 1,400 patients. "We are excited to advance to Phase III clinical studies with boceprevir in combination with Pegintron and Rebetol," said Fred Poordad, co-principal investigator of the Phase III study in treatment-naive patients. "These studies are designed to demonstrate that this combination therapy has the potential to benefit a broad range of patients by significantly increasing sustained response rates with a potentially shorter course of treatment," he added.