CONSHOHOCKEN, Pa., Sept. 03, 2020 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) announced today that it has already exceeded the originally targeted enrollment of 700 patients in its MAESTRO NAFLD-1 clinical trial of resmetirom in patients with NASH and fibrosis that is diagnosed using non-invasive assessments. Resmetirom is the first orally administered, small-molecule, liver-directed, truly β-selective thyroid hormone receptor (THR) agonist currently in Phase 3 development for the treatment of NASH patients with fibrosis stage 2-3 (ClinicalTrials.gov NCT03900429 and ClinicalTrials.gov/NCT04197479).

MAESTRO-NAFLD-1, was originally planned to enroll 700 patients with non-alcoholic fatty liver disease (NAFLD), presumed NASH, 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.  MAESTRO-NAFLD-1 enrollment has already exceeded the enrollment targets in the three double-blinded arms and in the open label arm. Although new screening of patients for the double-blind arms has ended, eligible patients who have already screened for the study will continue to enroll over the next few weeks.

Dr. Stephen Harrison, M.D., Medical Director for Pinnacle Clinical Research, San Antonio, Texas, and Visiting Professor of Hepatology, Oxford University, and Principal Investigator of the MAESTRO studies commented, “MAESTRO-NAFLD-1 has exceeded expectations in terms of enrollment, even during the COVID pandemic, that attests to the high prevalence of NASH and the enthusiasm of patients and investigators to participate in a Phase 3 clinical trial in which the NASH diagnosis is made without a liver biopsy. The ultimate goals of the biomarker tests and liver imaging, which have expanded rapidly in the past few years, are to diagnose NASH with fibrosis non-invasively in order to identify patients with high risk fatty liver disease.”

“We are pleased to have achieved our target enrollment in the MAESTRO-NAFLD-1 trial,” stated Paul Friedman, M.D., Madrigal’s Chief Executive Officer.  “We plan to complete enrollment in the double-blind arms of this study near the beginning of October to enable us to report topline 52-week data by the end of next year as planned. We intend to present data from the ongoing open label arm before the end of 2020.”

Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal, stated, “We are encouraged by patient participation in our Phase 3 MAESTRO-NASH and MAESTRO-NAFLD-1 studies of resmetirom, a once daily oral medication.  We recently began and will continue to enroll patients with compensated NASH cirrhosis into the open label arm of MAESTRO-NAFLD-1 to collect exploratory efficacy and safety data in this important population.  We believe the data from additional enrolled NASH patients in the double-blind arms and patients with NASH cirrhosis will reinforce the safety and efficacy of resmetirom and provide an even more robust safety data base for our Phase 3 NASH program.”

Dr. Taub continued, “As we have recently reported, including in presentations by NASH experts over the past week at the Digital International Liver Congress™ 2020 (EASL), secondary analyses of data from our Phase 2 NASH study demonstrate that liver fat reduction at three months after starting treatment has clear predictive power for NASH resolution and fibrosis reduction on subsequent liver biopsy.  Further, once daily oral 80 mg and 100 mg Phase 3 doses of resmetirom deliver at least 50% reduction in liver fat, and, based on secondary analyses of Phase 2 data, are associated with a statistically significant reduction in all components of NASH, including 64% NASH resolution (p60% had fibrosis reduction.  Finally, data from these analyses demonstrate that resmetirom robustly and statistically significantly (p