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Nov 17, 2008
 |  BioCentury  |  Product Development

Ganging up on HCV

There has long been agreement in the clinical community that in certain diseases it would make sense to test two unapproved compounds together rather than adding each separately to an approved regimen and waiting to combine them until at least one reaches the market. But the regulatory pitfalls of proving which compound contributes what degree of efficacy and side effects have discouraged such efforts.

A case in point is HCV, in which combining several compounds with the potential to block multiple aspects of viral replication ultimately could supplant the suboptimal interferon-based standard of care.

Despite a lack of regulatory clarity from FDA on the design of studies involving multiple unapproved HCV agents, Roche has devised a strategy that will allow it to run a parallel development program for two in-licensed compounds: R7128, a polymerase inhibitor from Pharmasset Inc., and R7227 (ITMN-191), a protease inhibitor from InterMune Inc. Roche has worldwide development rights to both programs.

The pharma last week began the Phase Ib INFORM-1 trial that will evaluate the R7128 and R7227 together without IFN. Both already have been evaluated in Phase I trials in combination with standard IFN-based therapy.

In a Phase I trial in 50 treatment-naïve patients, 1,500...

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