Madrigal Pharmaceuticals announces three abstracts to be presented at The Liver Meeting Digital Experience in November 2020, including phase III MAESTRO-NAFLD-1 trial.

Madrigal Pharmaceuticals, Inc. announced that, based on data from studies with MGL 3196 (resmetirom), three posters and an oral presentation of these data will be presented at The Liver Meeting Digital Experience thee American Association for the Study of Liver Diseases Meeting in November 2020. Biomarkers and Biopsy : Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal, stated, “The data from the ongoing open label arm of MAESTRO-NAFLD-1 confirm the robust effects of a 100 mg dose of resmetirom with direct actions in the liver at 16 weeks to statistically significantly reduce, compared to baseline, both hepatic fat on serial MRIPDFF as well as meaningfully reduce a measure of liver fibrosis assessed by serial MRE. MRIPDFF reduction was 53% overall and up to 62% in key subgroups. Marked lowering (p<0.0001) of multiple atherogenic lipids and lipoproteins was also observed, including ldl-c and apolipoprotein b>22%, triglycerides >25% and lipoprotein (a) >30%. These data at a dose used in the ongoing serial liver biopsy study, MAESTRO-NASH, predict that a high percentage of MAESTRO-NASH patients will achieve a level of liver fat reduction that has been shown, with this mechanism of action, to be associated with improvement in NASH and liver fibrosis on liver biopsy.”. Poster Presentations : Algorithm for predicting NASH fibrosis on screening biopsy in resmetirom Phase III MAESTRO-NASH -clinical trial . MAESTRO-NASH is a Phase III double-blind placebo-controlled serial liver biopsy study to evaluate resmetirom for the treatment of NASH with F2 or F3 fibrosis and an exploratory F1 arm. Data was assessed for the power of the screening paradigm to predict eligible NASH with fibrosis on liver biopsy. These data suggest that PRO-C3 is a marker not only of fibrosis stage in NASH but also of the level of NASH activity (inflammation and ballooning) in the NASH liver. In the absence of a liver biopsy, elevated PRO-C3 in the setting of metabolic syndrome (or FIBC3 (PRO-C3 [age, BMI, platelets, T2D]), fibroscan and MRI-PDFF may predict advanced NASH. Treatment with resmetirom in Phase II MAESTRO-NAFLD-1 NASH study open label arm: effects on biomarkers and imaging.:Data from the ongoing Open Label Arm of Madrigal’s MAESTRO-NAFLD-1 trial will be presented.In this 52 week Phase III open label study, NASH patients identified using non-invasive imaging and biomarkers were treated with resmetirom 100 mg and demonstrated rapid reduction in hepatic fat, biomarkers and atherogenic lipids after 12-16 weeks of treatment, potentially supporting use of non-invasive tests to monitor individual NASH patient response to resmetirom treatment. Improvement of health related quality of life is associated with improvement of fat fraction by MRI-PDFF in NASH patients treated with resmetirom: A review of patient reported outcome data from resmetirom’s Phase II NASH study demonstrates that NASH patients treated with resmetirom who had liver fat reduction also improved some quality of life measures, particularly physical components such as bodily pain. Ongoing Phase III studies will assess long-term sustainability of quality of life improvements with resmetirom treatment..