Resmetirom does not impact the thyroid axis hormones, including the central thyroid axis. 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 has been shown to be highly selective based on 1) THR-β receptor functional selectivity based on both in vitro and in vivo assays and 2) specific uptake into the liver, its site of action, virtually avoiding any uptake into tissues outside the liver.
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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. The lack of selectivity of older thyromimetic compounds, chemically-related toxicities and undesirable distribution in the body led to safety concerns. 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. Patients with NASH have reduced levels of thyroid hormone activity in the liver with resultant impaired hepatic function, in part due to the inflamed state of the liver that causes degradation of thyroid hormone. 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. 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. Ongoing Phase 3 studies will assess long-term sustainability of quality of life improvements with resmetirom treatment. Stephen A Harrison 5, (1) Center for Liver Disease, Department of Medicine, Inova Health System, (2) Center for Outcomes Research in Liver Diseases, Washington, DC, United States, (3) Madrigal Pharmaceuticals, (4) Medical, Adobe Gastroenterology, (5) Pinnacle Clinical ResearchĪ review of patient reported outcome data from resmetirom’s Phase 2 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. Younossi, MD, MPH, FAASLD 1, Maria Stepanova 2, Dr. #1675 IMPROVEMENT OF HEALTH-RELATED QUALITY OF LIFE IS ASSOCIATED WITH IMPROVEMENT OF FAT FRACTION BY MRI-PDFF IN PATIENTS WITH NONALCOHOLIC STEATOHEPATITIS TREATED WITH RESMETIROMĭr.At week 16, MRI-PDFF (magnetic resonance imaging-proton density fat fraction) reduction compared to baseline was 53% overall (p2.9, F1-F3).In the 100 mg open label arm of MAESTRO-NAFLD :.Stephen Harrison will present Resmetirom for the Treatment of NASH: Early Data from the Phase 3 MAESTRO Clinical Trials | The Liver Meeting Digital Experience™, AASLD Product Theater on Friday, November 13, 2020, at 4:30 PM ET. Ruben Mesa was part of the international research team that led the development and approval of fedratinib, becoming the 2nd drug that can be used to treat myelofibrosis, after huge success in Phase 3 trial, JAKARTA. New Drug Approved for Treating Rare Blood Cancerĭr.Hospitals across the country are conducting the study, which is funded by the U.S. The study will include adults and children older than 14 years with severe brain injury requiring admission to the ICU with brain monitoring. Study will compare 2 treatment strategies for severe brain injury public comment requestedĪ study of emergency care involving victims of severe brain trauma is to be performed in the San Antonio area.Jisook Ko, assistant professor in the School of Nursing, who is a scientist of the Asian Resource Center for Minority Aging Research supported by the National Institute on Aging was selected to receive a pilot grant of $34,920. Pilot study aims to improve diet patterns in Asian Americans with diabetesĭr.