Madrigal Pharmaceuticals Offers Resmetirom to Patients in Planned Open-Label Active Therapy Extension of the MAESTRO-NAFLD-1 Phase 3 Clinical Study


CONSHOHOCKEN, Pa., July 13, 2021 (GLOBE NEWSWIRE) – Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) today announced that its first patient has received a dose in an extension study of active therapy in 52-week scheduled opening of MAESTRO-NAFLD-1, named MAESTRO-NAFLD-1-Open Label Extension (OLE) (NCT04951219). MAESTRO-NAFLD-1 is a non-invasive, multicenter, double-blind, randomized, placebo-controlled phase 3 study lasting 52 weeks in approximately 1,200 patients of resmetirom in patients with fatty liver disease. non-alcoholic (NAFLD), presumed NASH. The study is expected to end later this year with safety and efficacy measures, including a reduction in imaging and measurements of NASH biomarkers, as well as lowering LDL cholesterol and others. atherogenic lipids.

MAESTRO-NAFLD-OLE allows patients who complete MAESTRO-NAFLD-1 to consent to 52 weeks of active treatment with resmetirom, making this treatment available for patients who were assigned to placebo in the main study and allowing patients who were on resmetirom to continue treatment with the drug.

“Patients and physicians participating in MAESTRO-NAFLD-1 are excited to continue active treatment with resmetirom in the extension study,” said Becky Taub, MD, medical director and research president and the development of Madrigal. “We have had positive results with resmetirom in our phase 2 clinical trial, and recently reported results from the open arm during phase 3 MAESTRO-NAFLD-1. NASH is a chronic disease that will require long-term dosing and the extension study will generate additional valuable data on safety and efficacy. “

About Madrigal Pharmaceuticals

Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a clinical-stage biopharmaceutical company pursuing novel therapies targeting a specific thyroid hormone receptor pathway in the liver, which is a key regulatory mechanism common to a range of cardiac diseases. metabolic and fatty liver disease with high unmet medical need. Madrigal’s lead candidate, resmetirom, is a first-class, orally administered, small-molecule, selective thyroid hormone receptor (THR) -β agonist currently in two phase clinical studies 3, MAESTRO-NASH and MAESTRO-NAFLD-1, designed to demonstrate multiple benefits in a broad spectrum of NASH (non-alcoholic steatohepatitis) and NAFLD (non-alcoholic fatty liver disease) patients. For more information, visit

Forward-looking statements

This communication contains “forward-looking statements” made in accordance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which are based on our beliefs and assumptions and on information currently available to us, but are subject to independent factors. of our will. Forward-looking statements include, without limitation, statements or references regarding: our clinical trials; research and development activities; the timing and results associated with the future development of our flagship product candidate, MGL-3196 (resmetirom); our primary and secondary endpoints for resmetirom and the potential to meet those endpoints and projections; plans, goals and schedulefor submitting a Subpart H (Expedited Approval of New Drugs for Serious or Life-threatening Illness) Subpart H application to the FDA; optimal dosage levels for resmetirom; projections regarding the potential future resolution of NASH, safety, treatment of fibrosis, cardiovascular effects, lipid treatment or biomarker effects with resmetirom; the efficacy and safety of resmetirom for non-cirrhotic NASH patients and cirrhotic NASH patients; the predictive power of the reduction of hepatic fat measured by non-invasive tests on the resolution of NASH with reduction or improvement of fibrosis; the achievement of recruitment objectives regarding the number of patients, the safety database and / or the schedule of our studies; the predictive power of resolution of NASH and / or reduction of hepatic fibrosis with resmetirom using non-invasive tests, including the use of ELF, FibroScan, MRE and / or IRM-PDFF; the predictive power of non-invasive tests in general, including for purposes of diagnosing NASH, monitoring patient response to resmetirom, or recruiting a clinical trial for NASH; potential benefits of the risk profile of NASH or NAFLD patients with resmetirom; the potential of resmetirom become the best therapeutic option and / or the first on the market for patients with NASH; and our possible or expected future operating results and expenses, business strategies and plans, capital requirements and financing plans, trends, market size, competitive position, industrial environment and potential growth opportunities, among others. Forward-looking statements: reflect the current knowledge, assumptions, judgment and expectations of management regarding future performance or events; include all statements that are not historical facts; and can be identified by terms such as “allow”, “anticipate”, “be”, “believe”, “continue”, “could”, “demonstrate”, “conceive”, “estimate”, “expect”. “,” Foresee “”, “future”, “objective”, “hope”, “inform”, “intention”, “may”, “could”, “plans”, “positions”, “potential”, ” powers ”,“ predicted ”,“ predictive ”,“ projects ”,“ seeks ”,“ should ”,“ will ”,“ would ”or similar expressions and the negative aspects of these terms. Although management currently believes that the expectations reflected in these forward-looking statements are reasonable, it cannot guarantee that these expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. .

Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to: our clinical development of resmetirom; uncertainties related to registrations, in general and in relation to measures related to COVID-19 that may be maintained for an uncertain period or implemented; competitive research results or trends; the timing or future results of frontline data; the risks of obtaining potential benefits in studies that include many more patients than our previous studies; limitations associated with data from early-stage non-placebo-controlled studies; the timing and results of clinical studies with resmetirom; and the uncertainties inherent in clinical trials. You should not place undue reliance on forward-looking statements, which speak only as of the date on which they are made. Madrigal makes no commitment 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 unforeseen events. Please refer to documents filed by Madrigal with the United States Securities and Exchange Commission for more detailed information regarding these risks and uncertainties and other factors that could cause actual results to differ materially from those expressed or implied. We specifically discuss these risks and uncertainties in more detail in the section titled “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2020, as well as in our other filings with the SEC. .

Investor contact:
Alex Howarth, Madrigal Pharmaceuticals, Inc.,

Media contact:
Mike Beyer, Sam Brown Inc.,, 312-961-2502

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