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S3-E25.1 – NASH Drug Development in 2022: Late-Stage NASH Drugs and Their Path to Market

Stephen Harrison discusses the state of NASH Drug Development in 2022 with focus on the key steps on the pathway and how late-stage NASH drugs are progressing

This conversation is part of a broader overview of NASH drug development in 2022, led by Stephen Harrison and Jörn Schattenberg.

Stephen starts this conversation by noting that the mechanics of the drug development pathway, which we discussed earlier this year in the context of NASH-TAG and strategies on how to shift away from traditional metrics, remain what they have been: same conditional endpoints (fibrosis improvement without worsening NASH or NASH resolution without worsening fibrosis, or improving both) and the same need for biopsy read as is has been. In this context, Stephen explains the difference between dual primary endpoints and co-primary endpoints in the context of a recent announcement from Madrigal.

From there, he goes on to list the various drugs and modes of action in different stages of development, starting with the five agents in Phase 3, then working his way back through the Phase 2b studies to discuss some of the more significant or interesting agents earlier in development.

This episode and all its conversations are sponsored by Madrigal Pharmaceuticals. Conversations 25.5 and 25.6 are a two-part summary of Madrigal’s disease-focused presentation at the recent CLDF LiverConnect meeting.

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