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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.
Teva api is an international pharmaceutical company headquartered in Israel.
Interspond is a Trial Management Organization (TMO) that works with a network of multi therapeutic sites across the country to facilitate clinical and pharmaceutical research and trials.
Alvogen is a multinational, privately owned pharmaceuticals company focused on developing, manufacturing and distributing generic, brand, over-the-counter brands (OTC) and biosimilar products. With more than 200 pharmaceutical projects in development and registration, the group`s product portfolio consists of a broad range of leading molecules for the treatment of conditions in the fields of: oncology, cardiology, respiratory, neurology and gastroenterology. Alvogen has commercial operations in over 30 countries with 2,000 employees. North America is Alvogen`s single largest market and other key markets include: South-Korea, Romania, Bulgaria, Hungary, Taiwan, Russia and China.
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