Regado Biosciences' REG1 Anticoagulation System Study Results Published in the Journal of Thrombosis and H...( Phase 1c Study Demonstrates Dose-dep...)

Phase 1c Study Demonstrates Dose-dependent Activity of Antidote Component

DURHAM, N.C., May 14 /PRNewswire/ -- Regado Biosciences today announced the Journal of Thrombosis and Haemostasis, the official journal of the International Society on Thrombosis and Haemostasis, has published the Phase 1c clinical results of the Company's REG1 anticoagulation system. 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 demonstrated RB007's ability to reverse the anticoagulant effect of RB006 either completely or partially, depending on the level of dosing of RB007.

The article, titled "A randomized, repeat dose, pharmacodynamic, and safety study of an antidote-controlled factor IXa inhibitor," was authored by Mark Y. Chan, Duke Clinical Research Institute (DCRI); Christopher P. Rusconi, Regado Biosciences; John H. Alexander, DCRI; Ross M. Tonkens, Regado; Robert A. Harrington, DCRI; and Richard C. Becker, DCRI. 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, administration 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.

"The Phase 1c results provide important validation of the activity of the REG1 system in the clinical setting," stated Doug Gooding, Chief Executive Officer of Regado Biosciences. "Specifically, the study confirmed the ability for physicians to titrate the RB007 component and therefore reverse or neutralize the anticoagulant effect of RB006. If the remainder of our clinical studies confirms these results, this flexibility represents a potentially significant advance in anticoagulation therapy. We are very pleased these results have been published
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