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Regado is currently evaluating REG1 in 26 patients undergoing elective percutaneous coronary intervention (PCI). The multi-center, open-label, randomized Phase IIa study designated REVERSAL-PCI will assess whether REG1 can replace standard heparin therapy during the performance of PCI with stenting.
REG1 is the first specific, direct-acting anticoagulant controllable by its matched reversal agent. Regado is developing REG1 for use in patients suffering from acute coronary syndrome who undergo coronary revascularization procedures. These procedures, which include percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), put patients at a high risk for therapy-related bleeding complications. REG1 is being developed initially to increase therapeutic flexibility and improve patient outcomes in coronary revascularization procedures. Intellectual property covering this technology derives from work originating in Duke University Medical Center's Division of Surgical Sciences, which was not involved in the subsequent clinical studies. Duke exclusively licensed the technology to Regado and will receive certain payments from Regado under this license.
REG1 is a two-component system, consisting of an aptamer-based anticoagulant and its matched reversal agent. The REG1 anticoagulant component, RB006, is a single-stranded, nucleic acid aptamer. RB006 selectively and potently binds to and inhibits factor IXa, a protein that is critical to blood coagulation. The reversal agent, RB007, is a complementary nucleic acid that binds to and neutralizes RB006. The amount of RB007 administered allows physicians to fine tune the pharmacodynamic effect of RB006, from slight reduction in anticoagulation all the way to complete reversal.
About Regado Biosciences
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