www.hivandhepatitis.com
SUMMARY: Abbott and Enanta Pharmaceuticals announced this week that they will initiate a Phase 2 clinical trial to test for 3 directly targeted oral drugs for hepatitis C virus (HCV) infection, the protease inhibitor ABT-450 (from the Abbott/Enanta collaboration) and 2 Abbott HCV polymerase inhibitors, ABT-333 and ABT-072. Each agent will be studied in combination with pegylated interferon plus ribavirin standard therapy now, but offer the potential for all-oral regimens in the future.
With the most advanced directly targeted oral hepatitis C drug now in Phase 3 trials, investigators have begun to look at all-oral combination regimens, which are expected to slow emergence of resistance and could potentially allow people with hepatitis C to avoid the side effects of pegylated interferon and ribavirin.
Roche/Genentech was the first to test such a combination, the HCV protease inhibitor RG7227 (also known as ITMN-191) plus the polymerase inhibitor RG7128; the first results from the INFORM-1 trial were presented this past fall. Vertex also announced this week that it will soon start studies of combination regimens containing its lead HCV protease inhibitor telaprevir plus the investigational HCV polymerase inhibitor VX-222.
Below is an excerpt from the recent Abbott/Enanta press release announcing their forthcoming studies.
Abbott and Enanta Announce Advancement of Hepatitis C Collaboration
Initiation of Phase 2 Clinical Trial
Investigating Three Individual HCV Antivirals
March 2, 2010. - Abbott and Enanta Pharmaceuticals announced today 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).
"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, MD, 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% 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, PhD, 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 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).
www.enanta.com www.abbott.com
3/5/10
Source
Abbott and Enanta Pharmaceuticals. Abbott and Enanta Announce Advancement of Hepatitis C Collaboration. Press release. March 2, 2010.
