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Milestone was founded in 2005 with the underlying concept to base its drug development programs on clinically validated mechanisms of action in order to mitigate as much drug development risk as possible. The company has raised a total of $34 million in venture capital financing since 2006. At its founding, the company assembled a panel of leading pharmaceutical R&D executives (“drug hunters”) each with an average of 30 years experience in drug development. The drug hunters proposed NCE projects based on clinically proven science to form the basis of Milestone’s drug development programs. Milestone has a seasoned management team with experience in cardiovascular diseases, drug development and business start-ups as well as world-class advisory boards of key opinion leaders with significant expertise in cardiology, regulatory affairs, as well as formulation and drug development.
Trevi Therapeutics, Inc. is a late-stage clinical development company developing Nalbuphine® ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic, and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with significant impairment in quality of life and increased mortality. Prurigo nodularis is an intensely pruritic dermatologic condition characterized by unsightly and itchy skin papules and nodules. There are no approved therapies in the United States or Europe for either condition.
BOCA PHARMACAL INC is a Pompano Beach, FL-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
Developing HIV prevention products for women worldwide
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.