Madrigal is excited to host four presentations by
- “Epidemiology of
NASH: CV- and Liver-related Outcomes” Zobair Younossi, MD, MPH, FACP, FACG, AGAF
Department of Medicine, Inova Fairfax Medical Campus. He is also Professor of Medicine, Virginia Commonwealth University, Inova Campus and Affiliate Professor of Biomedical Sciences at George Mason University. Dr. Younossifocuses on global prevalence and trends in NAFLD/ NASH, including the comprehensive burden of clinical, economic, and quality of life factors associated with the disease.
- “Resmetirom for the Treatment of NASH”
Stephen A. Harrison, MD
Visiting Professor of Hepatology,
Radcliffe Department of Medicine, University of Oxford, Oxford, Englandand MedicalDirector Pinnacle Clinical Research San Antonio, TX Dr. Harrisondiscusses the non-invasive and clinical identification of patients at high risk for NASHwith fibrosis, highlighting findings from the resmetirom clinical trial program.
- “Real-life Treatment of
NASH: Non-invasive Imaging in NASHDiagnosis and Treatment. Magnetic resonance imaging-proton density fat fraction (MRI-PDFF) to Predict Benefit in Patients with NASH: Focus on Resmetirom” Rohit Loomba, MD, MHSc
Professor of Medicine (with tenure),
Division of Gastroenterology, Department of Medicine, and Director, NAFLD Research Centerand Director, Liver Epidemiology Training Program, University of Californiaat San Diego Dr. Loombaprovides an overview of MRI-PDFF as a non-invasive diagnostic for NASHand discusses findings from a secondary analysis of the resmetirom Phase 2 study that examine MRI-PDFF response as a predictor of histologic response in patients with NASH.
- “The Intersection of CVD and
NASH, the Next CVD Prevention Frontier” Seth Baum, MD, FACC, FACPM, FAHA, FNLA,FASPC
Founder and CEO, Excel Medical Clinical Trials, and Clinical Affiliate Professor of Medicine at
Florida Atlantic University (FAU) Medical Schoolin Boca Raton, FL Dr. Baumhighlights topics of dyslipidemia, carotid-artery intimal medial thickness (CIMT), coronary artery calcification (CAC), and cardiovascular mortality in NAFLD/ NASH, in addition to the role of resmetirom as experts consider cardiovascular disease in the NASHtreatment landscape.
About Resmetirom (MGL-3196)
Thyroid hormone, through activation of its β-receptor in hepatocytes, plays a central role in liver function impacting a range of health parameters from levels of serum cholesterol and triglycerides to the pathological buildup of fat in the liver. Thyroid hormone receptor (THR)-β action in the liver is key to proper function of the liver, including regulation of mitochondrial activity such as breakdown of liver fat and control of the level of normal, healthy mitochondria. Patients with
To exploit the thyroid hormone receptor (THR)-β pathway for therapeutic purposes in cardio-metabolic and liver diseases, it is important to avoid activity at the THR-α receptor, the predominant systemic receptor for thyroid hormone that is responsible for activity outside the liver including in heart and bone. The lack of selectivity of older thyromimetic compounds, chemically-related toxicities and undesirable distribution in the body led to safety concerns. Madrigal recognized that greater selectivity for thyroid hormone receptor (THR)-β and liver targeting might overcome these challenges and deliver the full therapeutic potential of THR-β agonism. Resmetirom has been shown to be highly selective based on 1) THR- β receptor functional selectivity based on both in vitro and in vivo assays 2) specific uptake into the liver, its site of action, virtually avoiding any uptake into tissues outside the liver. In short and long term human and animal studies, resmetirom has been confirmed to be safe and devoid of activity at the THR-α receptor and without impact on bone or cardiac parameters. Resmetirom does not impact the thyroid axis hormones, including the central thyroid axis. Madrigal believes that resmetirom is the first orally administered, small-molecule, liver-directed, truly β-selective THR agonist.
About the Phase 3 Registration Program for the Treatment of
Analyses from the resmetirom Phase 2 NASH study demonstrate that the magnitude of liver fat reduction accurately predicts
The Phase 3 MAESTRO-
A second 52-week Phase 3 multi-center, double-blind, randomized, placebo-controlled study of resmetirom, MAESTRO-NAFLD-1, was initiated in
These and other data, including safety parameters, form the basis for potential subpart H submission to FDA for accelerated approval for the treatment of
About Resmetirom’s Potential to Confer Cardiovascular Risk Reduction in
Additionally, resmetirom lowers multiple atherogenic lipids, including LDL cholesterol, apolipoprotein B, triglycerides, and lipoprotein (a), as demonstrated in Phase 2, a key differentiating factor compared with other
Because of their diabetes, dyslipidemia, hypertension, obesity in concert with an inflamed, fatty liver,
This communication contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that are based on our beliefs and assumptions and on information currently available to us, but are subject to factors beyond our control. Forward-looking statements include but are not limited to statements or references concerning: our clinical trials; research and development activities; the timing and results associated with the future development of our lead product candidate, MGL-3196 (resmetirom); our primary and secondary study endpoints for resmetirom and the potential for achieving such endpoints and projections; optimal dosing levels for resmetirom; projections regarding potential future
Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to: our clinical development of resmetirom; enrollment uncertainties, generally and in relation to COVID-19 shelter-in-place and social distancing measures and individual precautionary measures that may be implemented or continued for an uncertain period of time; outcomes or trends from competitive studies; the risks of achieving potential benefits in studies that includes substantially more patients than our prior studies; the timing and outcomes of clinical studies of resmetirom; and the uncertainties inherent in clinical testing. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Madrigal undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Madrigal's filings with the
Source: Madrigal Pharmaceuticals, Inc.