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Tricida, Inc., is a pharmaceutical company focused on the development and commercialization of its drug candidate, TRC101, a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD). Metabolic acidosis is a chronic condition commonly caused by CKD that is believed to accelerate the progression of CKD, increase the risk of muscle wasting and cause the loss of bone density. Tricida has successfully completed all of the clinical trials that it planned to complete prior to submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), including a successful 135-subject, Phase 1/2 clinical trial (TRCA-101), a successful 217-subject, pivotal Phase 3 clinical trial (TRCA-301), and a successful 196-subject, Phase 3 extension trial (TRCA-301E). We plan to submit an NDA, in the second half of 2019, seeking approval of TRC101 through the FDA`s Accelerated Approval Program. Tricida was founded in August 2013 by a seasoned management team that has extensive experience in the development and commercialization of therapeutics, with substantial expertise in developing polymers for the treatment of kidney-related diseases. Tricida`s shared culture of teamwork, camaraderie and empowerment is evident in the dedication and focus our team demonstrates, with a commitment to the ultimate goal of improving and prolonging the lives of people living with CKD, and bringing critically needed new therapies to patients.
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.
Lilly makes medicines that help people live longer, healthier, more active lives. We were founded by Eli Lilly in 1876, and are now the 10th largest pharmaceutical company in the world. We have steadfastly remained independent, but not isolated. Across the globe, Lilly has developed productive alliances and partnerships that advance our capacity to develop innovative medicines at lower costs. Lilly is consistently ranked as one of the best companies in the world to work for, and generations of Lilly employees have sustained a culture that values excellence, integrity, and respect for people. We make medicines that help people live longer, healthier, more active lives.
"Syneos Health® (Nasdaq:SYNH) is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. We bring together a talented team of professionals, who work across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers` delivery of important therapies to patients. Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment. "
The Ripple Therapeutics Epidel® technology is founded on a discovery that drugs can be engineered into controlled release materials without the use of polymers or excipients. The proprietary prodrugs are new chemical entities (NCEs) that have unique properties that allow them to be processed into standalone drug delivery implants (e.g. intravitreal implants, micro/nanoparticles, etc.) or as coatings on medical devices. Ripple Therapeutics implants and coatings are made up entirely from the prodrug without a polymeric carrier to control the implant or drug release properties. The implants and coatings undergo surface erosion to give zero order drug release profiles and are highly engineerable (e.g. different forms, shapes, and sizes) to tailor drug dose and duration for the specific indication of interest. The flexibility in molecular design results in drug doses that are within the therapeutic window, delivering the right amount of drug for the right amount of time. This has the potential to improve patient safety and clinical outcomes.