Vertex Pharmaceuticals Incorporated reported encouraging results from a six- month interim analysis of an ongoing Phase II clinical trial with its novel drug merimepodib (VX-497) for the treatment of hepatitis C virus (HCV) infection. This 31-patient study is designed to evaluate the safety, tolerability and clinical activity of merimepodib administered in combination with pegylated interferon (peg-IFN) and ribavirin in HCV patients who were non-responsive to treatment with a previous course of interferon and ribavirin.
At six months, merimepodib met its primary endpoint of safety and tolerability and was not associated with any serious adverse events. At six months, merimepodib also met its secondary endpoint of clinical activity and demonstrated a statistically significant antiviral response in combination with pegylated interferon and ribavirin.
"In this six-month interim analysis, merimepodib was well tolerated and showed a statistically significant dose-dependent antiviral effect, suggesting that merimepodib may enhance the antiviral activity of pegylated interferon and ribavirin," stated John J. Alam, Senior Vice President of Drug Evaluation and Approval. "Based on the tolerability and clinical activity of merimepodib observed in the interim analysis of this study, we believe proof- of-mechanism for merimepodib in treatment-refractory patients has been obtained. The complete analysis, which will include 12-month treatment and six-month post-treatment data, will be used to guide the clinical path of merimepodib going forward."
Merimepodib is one of several drug candidates in Vertex's product portfolio that the Company is developing independently in the areas of infectious disease, autoimmune disease, inflammation and genetic disorders. Based on results from ongoing studies, as well as an analysis of market opportunity, Vertex expects to prioritize two drug candidates from this portfolio for full development and commercialization in high-value markets served by specialists. At the same time, Vertex will continue to pursue strategic alliances to maximize the near-term and downstream commercial value of certain research and clinical development programs. Vertex currently retains all worldwide development and commercial rights for merimepodib.