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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. To reflect on the insight-laden occasion, Stephen Harrison and Jörn Schattenberg join Roger Green to explore emerging drug development stories in detail.

This conversation focuses largely on therapeutic candidate, resmetirom, and a series of MAESTRO-NASH trials that will hopefully lead to a first drug approval and treatment for NASH. Stephen, lead Principal Investigator of the MAESTRO program, begins by outlining the resmetirom clinical trial package in its entirety. Before Stephen shares numbers from the trial, Jörn opens a discussion around efficacy endpoints. He notes the structure of reading biopsy and suggests that reporting improvement in fibrosis and NASH resolution might not accurately reflect the extent of efficacy once the MAESTRO outcomes trial completes several years from now and patients are treated in practice. Stephen goes on to share the efficacy outcomes of the MAESTRO-NASH trial and offers notes from several different perspectives around dosing, placebo, metrics and other elements of the study population. Finally, Stephen suggests where in the liver he believes the drug works and why the drug might have more robust effects than can currently be measured using the testing tools available.

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 [email protected].

Stay Safe and Surf On!