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 and the American Diabetes Association’s 83rd Scientific Sessions meeting. 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 continues on data presented by Stephen on the MAESTRO series of trials for resmetirom. It starts with a few clarifications on data presented in regards to liver volume. This discussion point evolves to consider how liver volume is not well understood and the three speculate what sort of useful insights can be derived from bridging that gap in knowledge. Stephen steers discussion back to the specific data by discussing the resmetirom safety profile. First, he shares the practical implications of safety for these drugs in everyday use. Next he provides an encouraging safety profile for the trial. As he does so, he shares thoughts about how to and how not to interpret a diahrea metric. Jörn responds by stating that the safety and liver volume profile suggest a reduction in liver pain and associated improvements to quality of life. He suggests the latter might be important with European regulators. As the conversation winds down, Stephen expresses his hope that the rolling submission with possible priority review and this profile will produce extremely positive news within the next 6 to 8 months.
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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