Regado’s anticoagulant shows promise in Phase I studies

The data showed that RB006 completely inhibited the activity of factor IXa, a protein essential to blood clotting, and RB006’s activity was rapidly and safely reversed by RB007 in the Phase I studies.

The Phase Ia study enrolled 84 healthy volunteers while the Phase Ib study enrolled 50 patients with stable coronary artery disease who were receiving aspirin with or without clopidogrel.

The results of the analysis showed an intravenous (IV) bolus injection of RB006 achieved in both study populations 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 1mg/kg dose of RB006 resulted in 100% factor IXa inhibition.

The studies 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 increase up to seven days. Despite dual antiplatelet use in 19 subjects, there were no major bleeding or other serious adverse events observed in either study.

Doug Gooding, CEO of Regado Biosciences, said: “Our Phase I studies consistently have confirmed the two major attributes of the REG1 system, the ability to rapidly anticoagulate and then reverse this effect.”