Business
Positive Resmetirom Data from Completed Open-Label Portion of Phase 3 MAESTRO-NAFLD-1 Clinical Study Presented at American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® Digital Experience 2021
This final read-out of the 52-week open-label resmetirom 100 mg treatment study of 171 patients with presumed non-alcoholic steatohepatitis (NASH) and
About this update from Madrigal Pharmaceuticals, Inc.
[{"type":"text","content":"This final read-out of the 52-week open-label resmetirom 100 mg treatment study of 171 patients with presumed non-alcoholic steatohepatitis (NASH) and fibrosis, identified using non-invasive tests, demonstrate that resmetirom: provided rapid and sustained reduction in liver fat and liver volume;provided rapid and sustained reductions in liver fibrosis, as measured by biomarkers, magnetic resonance elastography (MRE) and FibroScan; reduced atherogenic lipids, including LDLc and triglycerides, liver enzymes and inflammatory biomarkers; was safe and well-tolerated at 100 mg per day in patients treated for 52 weeks. This “real-life” study supports the potential use of non-invasive assessments to diagnose and manage NASH with fibrosis, including assessment of individual patient response to resmetirom treatment. CONSHOHOCKEN, Pa., Nov. 12, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), today announced the presentation of positive clinical data from the open-label portion of its ongoing MAESTRO-NAFLD-1 (non-alcoholic fatty liver disease) study of resmetirom at the AASLD The Liver Meeting®, being held virtually November 12th – 15th, 2021. Madrigal will host a webcast and conference call after the meeting on Tuesday, November 16th at 8:00 AM EST to summarize and discuss the data. “These new data from MAESTRO-NAFLD-1, our ongoing Phase 3 non-invasive study of resmetirom in patients with presumed NASH, reinforce and deepen our understanding of the therapeutic potential of resmetirom. The positive safety and efficacy findings from the open-label portion of MAESTRO-NAFLD-1 are particularly encouraging as we prepare to report initial topline data from the placebo-controlled double-blind portion of the study by year-end,” stated Paul Friedman, M.D., Chief Executive Officer of Madrigal. Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal added, “The completed 52-week open-label MAESTRO-NAFLD-1 results being presented at The Liver Meeting 2021 demonstrate resmetirom’s ability to potently reduce hepatic fat and liver volume in all subgroups of patients with NASH, including patients stably treated with diabetes medications such as GLP-1 agonists and SGLT2 inhibitors. Liver volume reduction may be explained in part by reduction in liver fat, but is also likely driven by other factors r...