Abbott and Enanta Pharmaceuticals (Enanta) have advanced their Hepatitis C (HCV) collaboration into Phase 2 clinical trials.
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The trial is expected to evaluate three HCV antiviral agents, including the investigational protease inhibitor ABT-450, part of the Abbott-Enanta collaboration and polymerase inhibitors ABT-333 and ABT-072 currently being developed exclusively by Abbott. Each antiviral agent will be dosed individually in combination with the current standard of care (SOC).
ABT-450 was discovered as part of an alliance between Abbott and Enanta. ABT-333 and ABT-072, both discovered internally at Abbott, are part of the company’s ongoing non-nucleoside polymerase inhibitor development program.
Reportedly, the objectives of the Phase 2 study are to assess the safety, tolerability, pharmacokinetics, and antiviral activity of multiple dose strengths of ABT-450 or ABT-333 or ABT-072, each dosed individually in treatment-naïve adults infected with HCV genotype 1.
The companies said that the initial antiviral activity will be evaluated via a 3-day monotherapy period. Subsequently, each antiviral agent will be administered with pegIFN/RBV (SOC) for 12-weeks, followed by treatment with SOC alone for an additional 36-weeks. Participants will then be monitored for sustained virologic response (SVR).
Jay Luly, president and CEO of Enanta, said: “Initiating Phase 2 is a key step in advancing our HCV collaboration. We look forward to working with Abbott to advance our shared vision of creating breakthrough treatments for HCV infection.”
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