Bristol-Myers Squibb has linked up with Johnson & Johnson to investigate its investigational oral drug daclatasvir in combination with Johnson & Johnson's TMC435 for the treatment of chronic hepatitis C.
A Phase II study beginning next year will look at the potential of daclatasvir, an oral NS5A replication complex inhibitor, in combination with J&J unit Tibotec Pharmaceuticals' TMC435, an experimental NS3 protease inhibitor, to achieve sustained viral response 12 and 24 weeks post-treatment in patients with HCV genotype 1. Seperately, both drugs are in Phase III development.
The study will have three arms - once-daily daclatasvir and TMC435 with pegylated-interferon alpha plus ribavirin, once-daily daclatasvir/TMC435/ ribavirin and the daclatasvir/TMC435 combo alone. Brian Daniels, head of development at B-MS, said the firms are looking to "advance the scientific understanding for the potential for an all-oral regimen of direct acting antivirals, which would be an important advancement for patients with HCV".
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