One theme in this week's episode involves different ways to use NITs in drug development and assessing the value of older drugs in MASH. This conversation, from our review of last September's FDA workshop on NITs, considers two additional roles that NITs might play in drug development.

The conversation includes Jörn Schattenberg, Louise Campbell, Roger Green, and guest Laurent Castera. The original post has an excellent description:

This conversation begins with a discussion of a point from a previous episode in 2022 about the difference between NITs to qualify patients for trials versus to evaluate the efficacy of drugs. This point stems from the idea that the way disease regresses may not be the same way it progresses. Laurent notes that NIMBLE and LITMUS have demonstrated important results with large data over the last two years. Jörn comments on the limits of using transaminase as a key NIT and Laurent replies by discussing a study over time that shows faster early declines on liver stiffness and slow declines over time as therapy might shift from reducing inflammation to regressing fibrosis. Louise shifts focus to ask about the relationship between kilopascal drops related to lifestyle change, specifically to ask whether these are false positives or real effects. Laurent notes that BMI is a confounder for liver stiffness and that CAP might help assess this issue. Finally, in response to a question from Louise, Laurent answers that we do not know about some of the key changes in test scores, and need to know more.

Plenty more ideas are explored as this is both a fascinating and pivotal workshop which covers a range of topics on NITs with presentations by the some of the field's most innovative and knowledgable contributors. If you have questions or comments around the workshop, NITs, drug development or any other themes addressed in this episode, we kindly ask that you submit reviews wherever you download the discourse.