HCV

Idenix Pharmaceuticals has entered into a non-exclusive collaboration with Janssen Pharmaceuticals to commence Phase II all-oral combination studies evaluating IDX719, simeprevir (TMC435) and TMC647055 for the treatment of hepatitis C virus (HCV).

The collaboration will focus on the clinical development of direct-acting antiviral (DAA) HCV combination therapies.

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Idenix president and chief executive officer Ron Renaud said the company is looking forward to initiating a Phase II study in the first quarter of 2013.

"This will allow us to achieve a key goal of ours for 2013, which is to advance the development of IDX719 as part of all-oral HCV combinations in two- and three-drug regimens," Renaud said.

IDX719 is Idenix’s once-daily pangenotypic NS5A inhibitor, and simeprevir (TMC435) is a once-daily protease inhibitor jointly developed by Janssen and Medivir.

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TMC647055, a once-daily non-nucleoside polymerase inhibitor being developed by Janssen, is boosted with low-dose ritonavir.

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According to the agreement, an initial drug-drug interaction study is expected to commence in the first quarter of 2013 subsequent to which Phase II studies will be conducted, all pending regulatory approvals.

The Phase II programme is designed to initially assess the two-DAA combination of IDX719 and simeprevir along with ribavirin for 12 weeks in HCV-infected patients new to the treatment.

Later a three-DAA combination of IDX719, simeprevir and TMC647055/r, with and without ribavirin, will be evaluated.

Idenix will conduct the clinical trials while both companies preserve all rights to their respective compounds under the deal.

Image: Electron micrographs of hepatitis C virus purified from cell culture. Scale bar is 50 nanometers. Photo: Courtesy of the Center for the Study of Hepatitis C, The Rockefeller University.