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Madrigal Pharmaceuticals Announces Presentation of Positive Clinical Data of Resmetirom from Open-Label Portion of Ongoing Phase 3 Clinical Trial MAESTRO-NAFLD-1 at The International Liver Congress™ 2021
Use of non-invasive measurements demonstrated that resmetirom: was safe and well-tolerated at 100 mg per day in non-cirrhotic NASH patients treated for 52
About this update from Madrigal Pharmaceuticals, Inc.
[{"type":"text","content":"Use of non-invasive measurements demonstrated that resmetirom: was safe and well-tolerated at 100 mg per day in non-cirrhotic NASH patients treated for 52 weeks;provided rapid and sustained reductions, measured by imaging and/or blood levels, of hepatic fat, fibrosis, liver cell injury and inflammation in non-cirrhotic NASH patients treated for 52 weeks;reduced atherogenic lipids in non-cirrhotic NASH patients treated for 52 weeks;was safe and well-tolerated, reduced hepatic fat, liver enzymes, fibrosis markers and atherogenic lipids in well-compensated cirrhotic NASH patients treated for up to 24 weeks. Study highlights the potential use of non-invasive assessments to diagnose NASH and monitor individual patient response to resmetirom treatment. CONSHOHOCKEN, Pa., June 25, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), today announced the presentation of positive clinical data from the open-label portion of its ongoing Phase 3 MAESTRO-NAFLD-1 study of resmetirom at the European Association for the Study of the Liver Annual Meeting, The International Liver Congress™ 2021, being held virtually, June 23-26, 2021. The data continue to position resmetirom as a promising treatment option for nonalcoholic steatohepatitis (NASH) patients. Resmetirom, a once daily oral, liver-directed, selective thyroid hormone receptor (THR) β agonist, is currently in Phase 3 development for the treatment of patients with NASH. The Phase 3 clinical program comprises (i) MAESTRO NAFLD-1 (non-alcoholic fatty liver disease) a 52-week ~1200 patient safety study in presumed NASH subjects diagnosed non-invasively and (ii) MAESTRO-NASH a 52-week serial liver biopsy study in more than 900 NASH subjects with biopsy-confirmed significant fibrosis. “Based on Phase 2 results, together with the open-label data from the ongoing MAESTRO-NAFLD-1 Phase 3 clinical trial, we remain confident that resmetirom has the potential to become the best-in-class and first-to-market treatment option for patients with NASH, especially those with significant liver fibrosis,” said Paul Friedman, M.D., Chief Executive Officer of Madrigal. “In the ongoing MAESTRO-NAFLD-1 Phase 3 clinical study that we characterize as a ‘real-life’ study of NASH, a series of non-invasive markers and imaging are used to diagnose and monitor NASH,” said Becky Taub, M.D., Chief Medic...