2:00 pm Roundtable Discussion: Navigating the Future of MASH Drug Development in the GLP-1 Era From Biopsy to Biomarker
Time: 2:00 pm
day: Conference Day 2
Details:
- A Paradigm Shift in Trial Design – The recent FDA acceptance of a non-invasive biomarker as a surrogate endpoint is a pivotal moment for drug development, which is set to transform clinical trials by reducing patient burden, improving recruitment and retention, and accelerating the path to regulatory approval for new therapies
- The New Therapeutic Foundation – The approval of GLP-1s for MASH by Novo Nordisk establishes this class of therapies as a core component of treatment, meaning future drug development strategies must now consider how to build upon the benefits of GLP-1s, focusing on combination or sequential therapies to achieve more complete disease resolution and patient outcomes
- Raising the Bar for Efficacy – The combination of GLP-1 success and the new FDA guidance signals a higher standard for what constitutes a successful MASH therapy so moving forward, developers will be challenged to design trials that not only address liver fibrosis but also demonstrate clear, quantifiable improvements using non-invasive methods, ultimately de-risking their pipelines
