Madrigal Presents New Data Demonstrating Rezdiffra® (resmetirom) Significantly Improved Multiple Noninvasive Imaging Tests and Biomarkers in Patients with Compensated MASH Cirrhosis

Core Insights - Madrigal Pharmaceuticals announced positive two-year data from the Phase 3 MAESTRO-NAFLD-1 trial for Rezdiffra, targeting compensated MASH cirrhosis patients, a population with no approved therapies [1][3][4] - The data presented at the AASLD meeting highlighted significant improvements in liver stiffness, liver enzymes, and biomarkers in patients with advanced compensated MASH cirrhosis [2][6][8] Company Overview - Madrigal Pharmaceuticals focuses on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) [23] - Rezdiffra (resmetirom) is the first approved medication for treating MASH with moderate to advanced fibrosis in the U.S. and Europe [12][23] Clinical Trial Results - In the MAESTRO-NAFLD-1 trial, Rezdiffra showed statistically significant improvements in multiple imaging and biomarker parameters over two years in patients with compensated MASH cirrhosis [4][6] - Patients with platelet counts <100,000/µL demonstrated notable improvements, with a mean reduction in liver stiffness of -7.9 kPa [5][7] - Following two years of treatment, 39% of patients shifted to no/low CSPH risk scores, indicating a positive trend in disease management [7] Health-Related Quality of Life - Rezdiffra treatment resulted in significant and sustained improvements in health-related quality of life measures across various domains for both cirrhotic and non-cirrhotic patients [9][10] - Improvements were observed in fatigue, worry, emotional function, and abdominal symptoms, enhancing overall patient well-being [10][12] Safety and Tolerability - Rezdiffra was well-tolerated in the high-risk patient population, with a low rate of discontinuation due to adverse events [8][12] - No significant changes in bone mineral density or fracture risk were noted over the two-year treatment period [8] Future Directions - Madrigal is executing a fully enrolled Phase 3 outcomes study for Rezdiffra in compensated MASH cirrhosis patients, reinforcing its commitment to addressing this unmet medical need [3][12] - Continuous treatment with Rezdiffra is emphasized as necessary to maintain benefits and prevent disease progression, similar to management strategies for chronic diseases [12]