Madrigal Announces New Two-Year Data from the Compensated MASH Cirrhosis Arm of the MAESTRO-NAFLD-1 Trial Demonstrating Potential Benefit of Rezdiffra™ (resmetirom) in Patients with Compensated MASH Cirrhosis

Core Insights - Madrigal Pharmaceuticals reported positive two-year results from the Phase 3 MAESTRO-NAFLD-1 trial of Rezdiffra, showing significant reductions in liver stiffness in patients with compensated MASH cirrhosis [1][2][4] Group 1: Trial Results - The trial included an open-label active treatment arm with 101 patients, achieving a mean reduction in liver stiffness of 6.7 kPa after two years, compared to a baseline of 25 kPa [2][6] - This reduction is the largest reported in an F4c MASH population, indicating a significant clinical improvement [2][6] - A responder analysis showed that 51% of patients achieved a ≥25% improvement in liver stiffness, which is associated with reduced progression to end-stage liver disease [3][6] Group 2: Safety and Efficacy - The safety profile of Rezdiffra in this cohort was consistent with previous trials, showing a low rate of discontinuations due to adverse events [4][5] - The ongoing MAESTRO-NASH OUTCOMES trial aims to further evaluate the efficacy of Rezdiffra in patients with compensated MASH cirrhosis, with the potential to become the first approved therapy for this indication [5][18] Group 3: Market Context - MASH is a serious liver disease that can progress to cirrhosis and has a high unmet medical need, with an estimated 1.5 million diagnosed patients in the U.S. [8][10] - Patients with compensated MASH cirrhosis face a 42 times higher risk of liver-related mortality, highlighting the urgency for effective treatments [9][10] - Madrigal aims to reach approximately 315,000 patients with moderate to advanced fibrosis under the care of liver specialists as awareness and prevalence of MASH increase [10][18]