Abbott and Enanta Pharmaceuticals announced the advancement of their Hepatitis C (HCV) collaboration into phase-2 clinical trials. The trial will 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 programme.
"Our scientists are working diligently to advance the treatment of Hepatitis C, which is a serious global epidemic that affects 170 million people worldwide," said John M Leonard, senior vice president, Global Pharmaceutical Research and Development, Abbott. "As a global leader in the development of antiviral therapies, we are focused on building an industry-leading pipeline for the treatment of HCV and are well-positioned to explore multiple potent and new classes of HCV therapies that hold promise for patients."
While significant progress has been made in HCV treatment, there are limitations in efficacy and safety for the current standard of care. An extended duration of treatment (24 or 48 week course of a combination of pegylated alpha interferon and ribavirin) still results in a less-than 50 per cent cure rate in those with HCV genotype 1. Additionally, the side-effects from interferon therapy can be highly problematic, often including depression and flu-like symptoms.
"Initiating phase-2 is a key step in advancing our HCV collaboration," said Jay R Luly, president and CEO of Enanta Pharmaceuticals. "We look forward to working with Abbott to advance our shared vision of creating breakthrough treatments for HCV infection."
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 most common and difficult to treat form of the infection in the developed world. Initial antiviral activity will be evaluated via a three-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).
Enanta Pharmaceuticals is a research and development company that uses its novel chemistry approach and drug discovery capabilities to create best in class small molecule drugs in the infectious disease field.