Expert Interview
Exploring the Potential of Madrigal Pharmaceuticals' Resmetirom in Treating NASH: Insights from the Phase 3 MAESTRO-NASH Trial
Ticker(s): MDGLInstitution: Imperial College London
- Consultant Hepatologist at Imperial College Healthcare NHS Trust, and Honorary Senior Lecturer at Imperial College London.
- Leads the NAFLD service in the Trust, overseeing a clinic that cares for more than 600 patients.
- Research interests are focused in translational aspects of NAFLD care, including prediction of cardiovascular risk, quantitation of liver biopsies from NAFLD patients using machine learning, and management of NAFLD cirrhosis.
Can you elaborate on how Resmetirom, as a THR-β agonist, functions in the treatment of NASH, particularly in reducing liver fat and fibrosis?
- How does Resmetirom's mechanism of action compare to other NASH treatments currently in development or in use?
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Based on the MAESTRO-NASH trial results, how effective is Resmetirom in improving liver health, particularly in reducing liver fat as measured by MRI-PDFF?
- What are the implications of the trial's finding that a ≥30% reduction in MRI-PDFF is a strong predictor of NASH resolution and fibrosis improvement?
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How significant are the advancements in noninvasive testing for NASH, as demonstrated in the MAESTRO-NASH trial, for the future management of the disease?
- Can you discuss the role of tests like MRI-PDFF, MRE, VCTE, CAP, and the ELF test in monitoring NASH progression and response to treatment?
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The trial indicated that Resmetirom reduces levels of LDL cholesterol and other lipids. How significant is this finding for patients with NASH, often associated with cardiovascular risks?
How does the use of artificial intelligence in biopsy reading, as seen in the MAESTRO-NASH trial, enhance the accuracy and reliability of clinical trial results?
With the FDA granting Priority Review for Resmetirom, what are your expectations regarding its potential approval and impact on NASH treatment?
- How might Resmetirom's approval influence the development of other NASH therapies?
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Considering the current landscape of NASH treatments, where does Resmetirom stand in terms of its potential market impact?
- Are there any emerging therapies that could compete with or complement Resmetirom's mechanism of action?
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Beyond NASH, do you foresee Resmetirom having implications for other liver conditions or metabolic disorders?
Given the unique nature of Resmetirom as a THR-β agonist, can you discuss any challenges or considerations in its large-scale production and distribution?
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