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S2-E43.2 – Rethinking Cirrhosis As A Target For Drug Development

Jörn Schattenberg joins the Surfers to discuss drug development in cirrhosis. This conversation focuses on why F4 might be a better target than F2/3.

This conversation focuses on specific reasons that initiating drug development in cirrhosis might offer unique benefits against the traditional model. Stephen Harrison starts off by discussing changing views of which cirrhosis patients are mostly likely to respond. After some comments from Louise Campbell about patient engagement, Stephen and Jörn Schattenberg discuss reasons that improvements in non-invasive testing, and particularly MR Elastography, might make cirrhosis the preferred target for drug development. As Stephen and Jörn explain, cirrhosis might make an easier target for the transition from a biopsy standard to an NIT standard, and both FDA and EMA have indicated that a drug could receive full approval based on a Phase 3 cirrhosis result, instead of the conditional approval the agencies are willing to grant in F2/3.

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