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HCV Protease VX950 Study Starts
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Vertex Pharmaceuticals Announces Start of Phase II Clinical Development for Investigational Oral Hepatitis C Virus Protease Inhibitor VX-950
- Investigational New Drug Application Activated in the U.S. -
press announcement from Vertex
CAMBRIDGE, Mass., Dec. 5 /PRNewswire-FirstCall/ -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today 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.
"This first Phase II study for VX-950 will enable Vertex to evaluate the safety, tolerability and pharmacodynamics of VX-950 over 28 days when combined with pegylated interferon and ribavirin," said John Alam, M.D., Senior Vice President of Drug Evaluation and Approval at Vertex. "This initial Phase II trial is anticipated to support the evaluation of VX-950 in a key three-month Phase II study in more than 200 HCV patients that we expect to initiate in early 2006."
Phase II Development Plans
The objectives of the 28-day Phase II study announced today 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.
Vertex recently completed a healthy volunteer study with the new VX-950 tablet formulation. Results from this study support the use of the VX-950 tablet formulation in Phase II studies.
About VX-950
VX-950 is an oral inhibitor of hepatitis C virus protease, an enzyme
essential for viral replication. In a 14-day, Phase Ib study concluded earlier in 2005, VX-950, administered as a single agent, produced a rapid and dramatic reduction in HCV RNA in HCV patients. In the Phase Ib study, 26 of 28 patients receiving any dose of VX-950 achieved more than a 3-log10 reduction in plasma HCV RNA within two days of treatment. After 14 days, patients in the best dose group (750 mg every 8 hours) achieved a mean reduction in HCV RNA of 4.4-log10, a 25,000-fold reduction in viral levels. Overall in the Phase Ib study, adverse events observed in patients receiving VX-950 that were considered possibly related to the drug were mild, and generally similar in frequency to events in the placebo group. The most common adverse events reported in both placebo and VX-950 patients were headache, frequent urination and gastrointestinal symptoms.
Vertex researchers were the first to solve the three-dimensional crystal structure of HCV protease, and have used structural insights to enable the design of small molecule HCV protease inhibitors, including VX-950.
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