| Name | Title | Contact Details |
|---|---|---|
Tricia McCormick |
General Counsel | Profile |
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.
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Based in Princeton, New Jersey, Oyster Point Pharma is a clinical stage pharmaceutical company leveraging neuroscience to discover, develop and commercialize novel therapies to treat diseases with high unmet needs. The company`s initial focus is to develop innovative therapeutics to treat the signs and symptoms of Dry Eye Disease (DED) by stimulating the trigeminal parasympathetic pathway to activate the glands responsible for tear film production. Oyster Point is leveraging a class of receptors called nicotinic acetylcholine receptors (nAChRs) which are located on the trigeminal nerve, accessible within the nose, to stimulate natural tear film production. The two lead product candidates, OC-01 and OC-02, are delivered via a nasal spray and are currently in Phase 2 trials for treatment of Dry Eye Disease (DED). Our leadership team brings extensive experience in developing and commercializing therapies for ophthalmic and other disease categories. Oyster Point is backed by industry leading investors, Versant Ventures and NEA and has an esteemed Board of Directors and Scientific and Medical Advisory Board.
MMS is an award-winning, global clinical research organization (CRO) that supports leading pharmaceutical and biotech companies as well as many smaller enterprises across our spectrum of services. Having completed more than 50 submissions for drug approval over the last 5 years, we remain a top choice for sponsors who are looking for innovation and demand high quality from their CRO partners. Senior leadership at MMS has more than two decades of hands-on drug development experience which helps support program-level strategy and execution of projects across multiple therapeutic areas. Continual staff training, innovative recruitment and motivating career opportunities help MMS retain the best talent and develop a strong, client-focused workforce across all global locations. Our mission is to deliver high-quality services, rooted in good science and decades of regulatory experience, that will assist our clients in developing and marketing life-changing therapies, thereby positively affecting patients` lives worldwide.