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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.
Paratek Pharmaceuticals, Inc., a biopharmaceutical company, focuses on the development and commercialization of antibacterial therapeutics based upon tetracycline chemistry in the United States. Its lead product candidate, omadacycline, is a tetracycline-derived and broad-spectrum antibiotic developed in oral tablet and intravenous formulations for use as a monotherapy antibiotic for acute bacterial skin and skin structure infections (ABSSSI), community-acquired bacterial pneumonia (CABP), urinary tract infections, and other serious community-acquired bacterial infections. The company has special protocol assessment agreements with Food and Drug Administration for the Phase III trials planned in ABSSSI and CABP. It is also developing sarecycline, a tetracycline-derived compound that is in Phase III clinical trials for use in the treatment of acne and rosacea. The company has collaborative research and license agreement with Actavis to research, develop, and commercialize tetracycline products; license agreement with Tufts University to develop and commercialize products for the treatment or prevention of bacterial or microbial diseases, or medical conditions; and collaboration agreement with Purdue Pharmaceuticals L.P. to commercialize Intermezzo. Paratek Pharmaceuticals, Inc. is headquartered in Boston, Massachusetts.
ABS Corporation is a Omaha, NE-based company in the Healthcare, Pharmaceuticals, and Biotech sector.