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news.Regado Biosciences has presented positive data from a Phase Ic study of its REG1 anticoagulation system, a two-component system comprised of an aptamer-based anticoagulant, RB006, and its matched antidote, RB007, which binds to and neutralizes RB006.
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The study results support RB007’s ability to reverse the anticoagulant effect of RB006 either completely or partially, depending on the level of dosing of RB007.
The study showed repeated doses of RB006 achieved highly reproducible increases in activated partial thromboplastin time (aPTT), a well-accepted surrogate marker of the blood’s ability to clot. Subsequently, repeat doses of RB007 reversed the aPTT levels dose-dependently and reproducibly. There were no major bleeding episodes or other serious adverse events reported in this study.
Regado’s lead product candidate, REG1, is the first specific, direct-acting, antidote-controlled anticoagulant ever described. Regado is developing REG1 for use in patients suffering from acute coronary syndrome who undergo coronary revascularization procedures.
Doug Gooding, CEO of Regado Biosciences, said: “The data from the Phase Ic study addressed important questions, particularly regarding the ability to titrate the RB007 component and therefore ‘dial down’ the anticoagulant effect of RB006. Based upon our Phase I study results, we developed an extensive Phase II program to evaluate REG1 in a variety of coronary revascularization settings. The first study is actively enrolling patients and we expect to initiate several additional studies over the coming months.”