S4-32 – Drug Development Stories from EASL and ADA: Part 1

S4-32 - Drug Development Stories from EASL and ADA: Part 1
Stephen Harrison and Jörn Schattenberg join Roger Green to discuss newly released Phase 3 MAESTRO-NASH data on resmetirom and the wider NASH therapeutic landscape, AI-assisted digital pathology, what the field understands about liver volume reduction, an increasing burden of cirrhosis and much more. This episode is packed with robust analysis and insights stemming from a busy past month at the EASL Congress and ADA Scientific Sessions meetings.

Throughout the month of July, Surfing NASH embarks on a series of episodes dedicated to takeaways emerging from a busy past month at both the 2023 EASL Congress in Vienna and the American Diabetes Association’s 83rd Scientific Sessions meeting in San Diego.

For this feature, Stephen Harrison and Jörn Schattenberg discuss at depth drug development insights emerging from the meetings with host Roger Green.

As lead Principle Investigator, Stephen expounds on Phase 3 MAESTRO-NASH data on resmetirom that he presented during the opening general session. He begins with a cogent backdrop of the study parameters, including endpoint criteria, before detailing results and implications. In his analysis, Stephen notes the challenges of teasing how well a drug performs in comparison to placebo. He then expands on the power of AI in digital pathology and its ability to enhance assessment of biopsy beyond ordinal scoring systems. Jörn adds that these extension studies are fascinating for their ability to hone in on patient benefits experienced beyond liver histology alone. From here, the group discusses at length deepening the field’s understanding of liver volume reduction.

Moving on, Roger revisits a metaphor from Mazen Noureddin in last week’s episode which likened the two most valuable properties in “NASH Monopoly” to GLP-1s and FGF-21s. Stephen suggests a takeaway to be that “GLP’s are coming to the forefront as a very active player in the fields of obesity, diabetes and ultimately CV risk reduction.” The group next agrees that, in Jörn’s paraphrased words, while a defatting effect on the liver can be beneficial, treating obesity by itself does not outright resolve fibrogenic burden and there remains the need for more liver-directed drugs. Stephen expands on his recurring phrase of “not all FGF-21s are created equal” while transitioning the group’s focus to consider the fact that an increasing number of patients are progressing to cirrhosis. The remainder of the conversation posits fascinating and far-reaching speculations on the future study of disease including revolutionizing the way we diagnose HCC. In final comments, each panelist touches on one additional element in the drug development landscape to emerge out of an exciting month of June.

If you have questions or comments around the EASL Congress or ADA meetings, the discussed therapeutics, new nomenclature, or any other topic addressed in this episode, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at questions@SurfingNASH.com.

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