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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.
Blade Therapeutics is a private biopharmaceutical company revolutionizing the treatment of fibrotic disease. Fibrosis, a pathologic process in which progressive scarring replaces functional tissue, drives the progression of several debilitating diseases. Uncontrolled, progressive fibrosis leads to organ dysfunction and failure, and potentially death. In the U.S., many millions of Americans are afflicted with a fibrosis-related disease, which may affect organs including the kidney, liver, lungs, skin, and eye.
Charleston Laboratories Inc is a Charleston, SC-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
Promentis Pharmaceuticals, Inc., is a privately held biopharmaceutical company focused on the discovery and development of first-in-class therapies to treat central nervous system (CNS) disorders. Promentis` drug development program is focused on activating a unique target known to restore glutamatergic neurotransmission and imbalances in oxidative stress, key contributors to impaired cortical function linked to multiple CNS disorders. The Company`s lead compound, SXC-2023, is being developed to treat various psychiatric disorders, with an initial focus on an indication that, despite representing a common disorder affecting millions of patients, has no FDA-approved treatment and a high level of patient need.
WHAT WE DO Cycle Pharmaceuticals is a global, privately-owned and patient-dedicated biotechnology company headquartered in Cambridge in the UK. Our mission is to utilise the latest pharmaceutical technologies to deliver superior drug treatments to b...