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XTuit Pharmaceuticals, Inc. is a biopharmaceutical company developing novel microenvironment-activated therapeutics targeting key mechanisms resulting in hypoxia, decreased drug uptake, drug resistance, and decreased immune response. The Company’s proprietary drug development pipeline and integrated, sophisticated clinical biomarker platform will be used for accelerated clinical development across selected cancers and fibrotic disorders. XTuit’s compounds act through pleiotropic mechanisms to inhibit extracellular matrix synthesis and stabilization, and to silence activated stromal cells, including cancer-associated fibroblasts and stellate cells. As a result, XTuit compounds alleviate hypoxia and enable enhanced drug uptake through solid stress reduction. Moreover, the drugs have been shown to down-regulate stroma-induced tumor and inflammation signaling pathways to overcome treatment resistance. XTuit’s first two lead series are being developed for early clinical proof-of-concept in liver diseases and cancer.
Navitas Pharma is a Laramie, WY-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
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.
AAA Pharmaceutical is a Lumberton, NJ-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
Sanofi SA is a French multinational pharmaceutical company headquartered in Paris, France, as of 2013 the worlds fifth-largest by prescription sales.