Regado Biosciences Announces Publication in Circulation of Clinical Trial Results of REG1 Anticoagulat...( - Phase 1b Study is First to Show R...),Health

- Phase 1b Study is First to Show RNA Aptamer Drug:Antidote Pair Offers Rapid Reversal of Anticoagulant Effect in Patients with Coronary Artery

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DURHAM, N.C., June 5 /PRNewswire/ -- Regado Biosciences today announced the journal Circulation has published clinical data from the Company's REG1 anticoagulation system Phase 1b dose-escalation study. REG1 is a two-component system comprised of an aptamer-based anticoagulant, RB006, and its matched antidote, RB007, which binds to and neutralizes RB006. The published study is the first to show in patients that RB006 effectively inhibited the activity of Factor IXa, a protein essential to blood clotting and that RB006's activity was reversed rapidly and safely by RB007.

The article, titled, "A Phase 1b Randomized Study of Antidote-Controlled Modulation of Factor IXa Activity in Patients with Stable Coronary Artery Disease", was authored by clinical researchers from the Duke Clinical Research Institute and Regado. The study showed an intravenous (IV) bolus injection of RB006 achieved a prompt, consistent, and dose-dependent prolongation of activated partial thromboplastin time (aPTT), a well-accepted surrogate marker of the blood's ability to clot. In addition, a 1 mg/kg dose of RB006 resulted in essentially complete Factor IXa inhibition. The study also demonstrated an IV bolus injection of RB007 administered in a 2:1 antidote:drug ratio successfully reversed prolonged aPTT within a median of one minute, with no rebound for up to seven days. There were no major bleeding or other serious adverse events observed in the study, which included 19 subjects who received dual antiplatelet therapy.

"The data published in Circulation provide further evidence of the REG1 system's ability to rapidly and predictably anticoagulate and then to reverse this effect as needed in a reproducible manner. The results also show the pharmacologic data translated well from heal
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