Madrigal Pharmaceuticals Announces Completion of Enrollment in Phase 3 MAESTRO NAFLD-1 Trial and Reports 2020 Third Quarter Financial Results and Highlights

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[{"type":"text","content":"CONSHOHOCKEN, Pa., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) announced today that it completed enrollment in its MAESTRO NAFLD-1 clinical trial of resmetirom in patients with presumed NASH who are diagnosed using non-invasive assessments. The Company also announced its third quarter 2020 financial results and highlights.\n The original target enrollment for MAESTRO NAFLD-1 was 700 patients, randomized 1:1:1 to receive resmetirom 80 mg once a day, 100 mg once a day, or placebo, and included an 100 mg resmetirom open label arm in up to 100 patients. The trial was expanded to include more than 1,200 patients, in order to significantly enhance resmetirom’s safety database and provide further opportunity to study selected patient subgroups. Resmetirom, an orally administered, small-molecule, liver-directed, truly β-selective thyroid hormone receptor (THR) agonist, is also currently in Phase 3 development in biopsy confirmed NASH patients with fibrosis stage 2-3 (MAESTRO-NASH) (ClinicalTrials.gov NCT03900429 and ClinicalTrials.gov/NCT04197479). Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal, stated, “We are pleased with the rapid enrollment of MAESTRO-NAFLD-1, and the overall enthusiasm of patients to participate in our Phase 3 NASH clinical development program. MAESTRO-NAFLD-1 is designed to be a ‘real-world’ NASH study, collecting safety and efficacy data in patients with presumed NASH, who are diagnosed and monitored using noninvasive methods. We believe this trial will also provide an even more robust safety data base for our Phase 3 NASH program.” Dr. Taub continued, “We expect that completion of enrollment in MAESTRO-NAFLD-1 will enable us to report topline 52-week data from the blinded arms of the study by the end of next year. As we recently reported, the upcoming The Liver Meeting Digital Experience™, The American Association for the Study of Liver Diseases Meeting, will include presentation of interim data from the open label arm of MAESTRO-NAFLD-1.” “The totality of the early data from the open label arm of MAESTRO-NAFLD-1, and data from Madrigal’s Phase 2 studies, continue to suggest that we can achieve the primary and secondary endpoints in our Phase 3 NASH program,” stated Paul Friedman, M.D., Chief Executive Officer of Madrigal. “Notably, ...

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