Vertex Pharmaceuticals: Start of Phase II Clinical Development for Investigational Oral Hepatitis C Virus Protease Inhibitor
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Vertex Pharmaceuticals Incorporated announced the initiation of a Phase II clinical trial for VX-950, an investigational oral hepatitis C virus (HCV) protease inhibitor for the treatment of HCV infection. The 28-day study will evaluate the safety, tolerability and pharmacodynamics of VX-950 when combined with pegylated interferon and ribavirin. Pegylated interferon and ribavirin are two approved treatments for HCV infection. Twelve treatment-naive subjects will be enrolled in the study at two centers in the United States.
This is the first clinical study of VX-950 to be initiated under an open investigational new drug (IND) application with the United States Food and Drug Administration, and marks the beginning of a broad Phase II clinical development program planned for VX-950 that will evaluate the compound in multiple clinical studies in 2006, including a three-month study in more than 200 treatment-naive patients.
The objectives of the 28-day Phase II study announced are to evaluate the safety, tolerability and pharmacodynamics of VX-950 dosed at 750 mg every eight hours with standard doses of pegylated interferon and ribavirin. Vertex expects to obtain 28-day results from this initial Phase II study in the first quarter of 2006. Following completion of 28 days of treatment, patients will receive the standard of care. In early 2006, Vertex expects to initiate a three-month Phase II clinical study in more than 200 treatment-naive subjects. A major objective of this three-month study, in addition to an evaluation of safety, will be to measure HCV RNA at the end of treatment and post-treatment as a measure for sustained viral response, potentially enabling a decision to move to Phase III clinical development of VX-950. Vertex also plans to initiate multiple other clinical studies throughout 2006.
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