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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.
Our name, Aptuit, is derived from the words aptitude and intuition, two natural attributes that define our unique approach to providing drug discovery, development and manufacturing support. The name communicates our aptitude for scientific knowledge as well as our intuitive understanding of the needs of the pharmaceutical and biotechnological community. We summon these attributes to clarify current challenges and anticipate those that are to come, always with the determination to find solutions. Since Aptuit was founded in 2004, we have forged a robust expansion of our resources. We are living up to the promise of our name by the ongoing assembly of experienced and talented scientists, and we are supporting them every step of the way with the most advanced resources at state-of-the art facilities. Our corporate tagline - Uncommon Expertise. Exceptional Results - reflects our success in harnessing unique and outstanding strengths in drug discovery and drug development to deliver the results that our clients demand.
APP Pharmaceuticals is one of the leading companies in the Healthcare, Pharmaceuticals, and Biotech sector.
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