Vertex Pharmaceuticals Inc announced the design of a phase IIb clinical study that it plans to conduct with merimepodib, an investigational oral therapy for the treatment of hepatitis C virus (HCV) infection, in patients who are non-responders to prior treatment with pegylated interferon (peg-IFN) and ribavirin.
The clinical trial will be conducted at centers in the United States and is expected to enroll approximately 315 patients who will receive merimepodib or placebo in combination with Pegasy (peginterferon alfa-2a) and Copegus (ribavirin). Roche will provide Pegasys and Copegus to Vertex for use in this study, providing support for the clinical development of merimepodib as an investigational agent that may enhance the antiviral activity of Pegasys and Copegus, which is the most frequently prescribed treatment combination for HCV infection in the United States.
As part of the supply agreement with Roche, Vertex will share data and data analysis with Roche at predetermined intervals during the course of the study. Vertex owns worldwide development and commercialization rights to merimepodib.
"HCV-infected patients who do not respond to initial combination therapy with pegylated interferon plus ribavirin face limited treatment options and the prospect of worsening liver disease," stated John J. Alam, senior vice president of Drug Evaluation and Approval at Vertex.
"Preclinical and clinical data reported to date for merimepodib, Vertex's lead oral therapy for HCV infection, have highlighted the potential for this drug candidate to enhance the standard of care in hepatitis C. In this phase IIb clinical trial, we will seek to evaluate the ability of a triple combination of merimepodib plus peginterferon alfa-2a and ribavirin to increase viral clearance in patients who are refractory to prior combination treatment."
Merimepodib Triple Combination Study (The METRO Study) The MErimepodib TRiple cOmbination study (the METRO study) has been designed as a double-blind, placebo-controlled, randomized phase IIb study, with a goal of evaluating the antiviral activity of two doses of merimepodib (MMPD) in combination with Pegasys and Copegus.