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Madrigal Pharmaceuticals 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. The Company has advanced its lead candidate, resmetirom, also known as MGL-3196, a first-in-class, orally administered, small-molecule, liver-directed, thyroid hormone receptor (THR) β-selective agonist, through Phase 2 clinical trials in NASH. Primary and key secondary endpoints were achieved including reduction of liver fat on a sensitive non-invasive imaging test, lowering of multiple atherogenic lipids including LDL-cholesterol and triglycerides, and resolution of NASH on liver biopsy. Based on evidence of broad activity and a favorable safety profile, Madrigal has initiated a Phase 3 clinical study in NASH patients with advanced liver fibrosis, MAESTRO-NASH, in which the primary endpoint after one year of dosing is resolution of NASH and key secondary endpoints include LDL-cholesterol lowering and reduction in liver fibrosis. Clinical benefit in reducing progression to more advanced liver disease, including cirrhosis, is a long-term goal of this trial. A second Phase 3 clinical study, MAESTRO-NAFLD-1, has also been initiated. This 52-week non-invasive study in a broader segment of NASH patients will provide additional safety information to support the NASH indication and will include key efficacy endpoints: LDL-cholesterol lowering, triglyceride lowering, reduction of liver fat as determined by MRI-PDFF, as well as reduction of elevated liver enzymes and reduction in fibrosis biomarkers. This is a non-biopsy study in people with NASH, as documented using non-invasive techniques or historical liver biopsy.
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The Heritage of Life Sciences Products HLS Therapeutics is about maintaining the heritage of life science products. We are dedicated to keeping trusted branded drugs on the market. HLS provides access to medications critical to Health Care Providers, patients and their caregivers with the high-quality brand names they trust. HLS Therapeutics Inc. is a specialty pharmaceutical company dedicating itself to acquiring and distributing commercial stage mature, or legacy, branded pharmaceutical drugs for the North American markets. Our management team is comprised of seasoned pharmaceutical executives with a strong track record of success. Building on the expertise of our founders, HLS is focused on treatment products for the central nervous system, soon to be followed by specialty products in other therapeutic areas. HLS Therapeutics focuses on the North American market and has operational locations in Toronto (Etobicoke, Ontario), and Philadelphia (Rosemont, Pennsylvania), We source our products from the drug`s originator or from best-in-class manufacturing partners, ensuring our brands are manufactured with the highest standards of quality and in compliance with FDA and Health Canada`s regulations. HLS is dedicated to the stewardship of branded pharmaceuticals through their life cycle during and post exclusivity, providing access to treatments critical to Health Care Providers, patients and their caregivers with the brand names they trust.