MDGL Madrigal Pharmaceuticals Inc

Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH), today announced the appointment of Michael R. Charlton, M.B.B.S., F.R.C.P., as Senior Vice President, Clinical Development, effective October 1, 2024.

Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal, stated, “I am thrilled to have Dr. Charlton joining the Madrigal team; his deep experience as a researcher and clinician treating patients with NASH will bring powerful new insights and capabilities to Madrigal as we shape the next phase of our R&D strategy.”

Bill Sibold, Chief Executive Officer of Madrigal, added, "Madrigal has established the most advanced and comprehensive clinical development program in NASH, and the appointment of Dr. Charlton reflects our commitment to continue innovating for patients. As a prominent global thought leader in the field, he will provide important strategic perspective to Madrigal and expand our partnerships with the hepatology community.”

Dr. Charlton has more than thirty years of leadership experience in hepatology, gastroenterology, and liver transplantation, with a particular expertise in NASH. He has held academic leadership roles at the Mayo Clinic, where he served as Director of Hepatology, the University of Chicago and Intermountain Medical Center. As Medical Director of the Transplant Institute at the University of Chicago, Dr. Charlton spearheaded innovative clinical programs targeting NASH and other liver disease. His extensive research in the pathophysiology and treatment of NASH has resulted in over 200 publications, including authoring guidelines for the evaluation and management of NASH for the American Association for the Study of Liver Diseases, among many significant contributions to the field, making him a key figure in both clinical and academic hepatology. Dr. Charlton received his M.B.B.S. from the University of London and is a Fellow of the Royal College of Physicians.

“I am excited to begin a new chapter of my career at Madrigal, a company at the forefront of innovation in NASH R&D,” said Dr. Charlton. “After 15 years of research and clinical development, Madrigal has energized the NASH field with a breakthrough therapy in Rezdiffra (resmetirom), and I believe this is just the beginning. I look forward to collaborating with my colleagues at Madrigal and our many partners in the hepatology community to drive new advances in care for patients with this serious disease.”

About NASH

Nonalcoholic steatohepatitis (NASH) is a more advanced form of nonalcoholic fatty liver disease (NAFLD). NASH is a leading cause of liver-related mortality and an increasing burden on healthcare systems globally. Additionally, patients with NASH, especially those with more advanced metabolic risk factors (hypertension, concomitant type 2 diabetes), are at increased risk for adverse cardiovascular events and increased morbidity and mortality.

Once patients progress to NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), the risk of adverse liver outcomes increases dramatically. NASH is rapidly becoming the leading cause of liver transplantation in the U.S. and is already the leading cause in women.

Madrigal estimates that approximately 1.5 million patients have been diagnosed with NASH in the U.S., of which approximately 525,000 have NASH with moderate to advanced liver fibrosis. Madrigal plans to focus on approximately 315,000 diagnosed patients with NASH with moderate to advanced liver fibrosis under the care of the liver specialist physicians during the launch of Rezdiffra.

NASH is also known as metabolic dysfunction associated steatohepatitis (MASH). In 2023, global liver disease medical societies and patient groups came together to rename the disease, with the goal of establishing an affirmative, non-stigmatizing name and diagnosis. Nonalcoholic fatty liver disease (NAFLD) was renamed metabolic dysfunction-associated steatotic liver disease (MASLD); NASH was renamed MASH; and an overarching term, steatotic liver disease (SLD), was established to capture multiple types of liver diseases associated with fat buildup in the liver. In addition to liver disease, patients with MASH have at least one related comorbid condition (e.g., obesity, hypertension, dyslipidemia, or type 2 diabetes).

About Madrigal Pharmaceuticals

Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), a liver disease with high unmet medical need. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of NASH.

For more information, visit www.madrigalpharma.com.

Investor Contact Tina Ventura, IR@madrigalpharma.com

Media ContactChristopher Frates, media@madrigalpharma.com