Madrigal Pharmaceuticals Offers Patients Resmetirom in a Planned Open Label Active Treatment Extension of the Phase 3 MAESTRO-NAFLD-1 Clinical Study
Madrigal Pharmaceuticals (NASDAQ: MDGL) has dosed its first patient in the MAESTRO-NAFLD-1 Open Label Extension (NCT04951219), following the completion of the MAESTRO-NAFLD-1 Phase 3 study. This 52-week study evaluates the efficacy of resmetirom in addressing non-alcoholic fatty liver disease (NAFLD), presumed non-alcoholic steatohepatitis (NASH). Patients previously on placebo can now receive active treatment, while those on resmetirom continue. Positive results have been reported from prior trials, strengthening prospects for future treatment success and additional data on safety and efficacy.
- Initiation of the Open Label Extension study allows continued access to resmetirom for patients.
- Positive prior trial results for resmetirom boost confidence in its efficacy.
- The ongoing Phase 3 study aims to gather more safety and efficacy data.
- None.
CONSHOHOCKEN, Pa., July 13, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) announced today its first patient dosed in a planned 52-week open label active treatment extension study of MAESTRO-NAFLD-1, named MAESTRO-NAFLD-1-Open Label Extension (OLE) (NCT04951219). MAESTRO-NAFLD-1 is an ongoing 52-week ~1200 patient Phase 3 non-invasive, multi-center, double-blind, randomized, placebo-controlled study of resmetirom in patients with non-alcoholic fatty liver disease (NAFLD), presumed NASH. The study is due to complete later this year with measures of safety and efficacy including reduction in imaging and biomarker measures of NASH, as well as the lowering of LDL-cholesterol and other 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 to 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 enthusiastic about the opportunity to continue active treatment with resmetirom in the extension study,” stated Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal. “We have achieved positive results with resmetirom in our Phase 2 clinical trial, and the recently reported results from the ongoing open-label arm of Phase 3 MAESTRO-NAFLD-1. NASH is a chronic disease that will require long-term dosing and the extension study will generate additional valuable safety and efficacy data.”
About Madrigal Pharmaceuticals
Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a clinical-stage biopharmaceutical company pursuing novel therapeutics that target a specific thyroid hormone receptor pathway in the liver, which is a key regulatory mechanism common to a spectrum of cardio-metabolic and fatty liver diseases with high unmet medical need. Madrigal’s lead candidate, resmetirom, is a first-in-class, orally administered, small-molecule, liver-directed, thyroid hormone receptor (THR)-β selective agonist that is in currently in two Phase 3 clinical studies, MAESTRO-NASH and MAESTRO- NAFLD-1, designed to demonstrate multiple benefits across a broad spectrum of NASH (non-alcoholic steatohepatitis) and NAFLD (non-alcoholic fatty liver disease) patients. For more information, visit www.madrigalpharma.com.
Forward-Looking Statements
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; plans, objectives and timing for making a Subpart H (Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses) submission to FDA; optimal dosing levels for resmetirom; projections regarding potential future NASH resolution, safety, fibrosis treatment, 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 liver fat reduction measured by non-invasive tests on NASH resolution with fibrosis reduction or improvement; the achievement of enrollment objectives concerning patient number, safety database and/or timing for our studies; the predictive power of NASH resolution and/or liver fibrosis reduction with resmetirom using non-invasive tests, including the use of ELF, FibroScan, MRE and/or MRI-PDFF; the predictive power of non-invasive tests generally, including for purposes of diagnosing NASH, monitoring patient response to resmetirom, or recruiting a NASH clinical trial; potential NASH or NAFLD patient risk profile benefits with resmetirom; the potential for resmetirom to become the best-in-class and/or first-to-market treatment option for patients with NASH; and our possible or assumed future results of operations and expenses, business strategies and plans, capital needs and financing plans, trends, market sizing, competitive position, industry environment and potential growth opportunities, among other things. Forward-looking statements: reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events; include all statements that are not historical facts; and can be identified by terms such as “allow,” “anticipates,” “be,” “believes,” “continue,” “could,” “demonstrates,” ”design,” “estimates,” “expects,” “forecasts,” “future,” “goal,” “hopeful,” ”inform,” “intends,” “may,” “might,” “plans,” “positions,” “potential,” “powers,” “predicts,” ”predictive,” “projects,” “seeks,” “should,” “will,” “would” or similar expressions and the negatives of those terms. Although management presently believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such 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; enrollment uncertainties, generally and in relation to COVID-19-related measures that may be continued for an uncertain period of time or implemented; outcomes or trends from competitive studies; future topline data timing or results; the risks of achieving potential benefits in studies that include substantially more patients than our prior studies; limitations associated with early stage, non-placebo controlled study data; 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 U.S. Securities and Exchange Commission for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied. We specifically discuss these risks and uncertainties in greater detail in the section entitled "Risk Factors" in 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., IR@madrigalpharma.com
Media Contact:
Mike Beyer, Sam Brown Inc., mikebeyer@sambrown.com, 312-961-2502
FAQ
What is the purpose of the MAESTRO-NAFLD-1 study?
What is resmetirom and its significance in treating NASH?
What are the next steps after the MAESTRO-NAFLD-1 study completion?
When is the MAESTRO-NAFLD-1 study expected to be completed?
What patient benefits are associated with the Open Label Extension study?
