Madrigal Pharmaceuticals Announces New Data from the Phase 3 MAESTRO-NASH Study of Rezdiffra™ (resmetirom) Presented at the EASL Congress

Core Insights - Rezdiffra shows potential in treating patients with NASH and moderate to advanced liver fibrosis by reversing fibrosis and preventing disease progression [1][28] - The Phase 3 MAESTRO-NASH trial demonstrated that Rezdiffra achieved both primary endpoints of fibrosis improvement and NASH resolution [10][28] - Rezdiffra treatment resulted in significant improvements in health-related quality of life (HRQL) for patients with NASH [4][5][28] Group 1: Treatment Efficacy - Noninvasive test data over three years indicate a durable treatment response to Rezdiffra, with 91% of treated patients showing improved or stable liver stiffness compared to placebo [2][28] - Both doses of Rezdiffra (80 mg and 100 mg) demonstrated similar improvements in liver stiffness and fat content, predicting fibrosis improvement and NASH resolution [3][28] - In patients with MetALD, Rezdiffra achieved fibrosis improvement rates of 88% for the 100 mg dose and 81% for the 80 mg dose, compared to 14% in the placebo group [7][28] Group 2: Health-Related Quality of Life - Patients receiving Rezdiffra showed significant improvements in HRQL scores, particularly in the Worry domain of the Chronic Liver Disease Questionnaire-NASH [5][28] - Biopsy responders with stage F3 fibrosis at baseline experienced more pronounced HRQL improvements compared to those with lower fibrosis stages [5][28] Group 3: Study Design and Future Directions - The MAESTRO-NASH trial enrolled 1,759 patients with biopsy-confirmed NASH, with ongoing studies to confirm clinical benefits over a 54-month period [8][11][28] - The trial's primary endpoints included NASH resolution without worsening fibrosis and improvement in fibrosis by at least one stage [9][28] - Continued approval for Rezdiffra may depend on the verification of clinical benefits in ongoing confirmatory trials [28]