The company believes that this is the first time a direct antiviral drug has reached this stage of clinical testing for this patient population. More than 170 treatment refractory patients with hepatitis C genotype 1 have been recruited.
Valopicitabine (NM283) is being evaluated in patients who have previously failed treatment with pegylated interferon plus ribavirin. The six-month head-to-head trial will compare combinations of valopicitabine and Roche’s Pegasys with ribavirin and Pegasys. Idenix expects to report initial clinical data from the trial later this year and anticipates initiating a phase III clinical trial in the first half of 2006.
“Today, there are very limited treatment options for treatment refractory hepatitis C patients, or patients that have failed prior treatment with existing hepatitis C therapies. Among this patient population, approximately 10% respond to retreatment with the current standard of care, pegylated interferon plus ribavirin,” said Dr Jean-Pierre Sommadossi, Idenix’ chairman and CEO.
Dr Jean-Pierre went on to explain the importance of the trial: “Since standard treatment is only effective in about half of genotype 1 patients, it is estimated that 30,000-40,000 patients in the US will fail treatment each year. Our development program for valopicitabine is seeking first to address this major, growing, unmet need.”
Valopicitabine is an oral, novel nucleoside analog. It is currently being developed in combination with pegylated interferon for use in both treatment refractory and treatment-naive patient populations.