Regado Reports First Patient Enrollment in RADAR Phase 2b Study

Regado Biosciences ( Regado) has reported enrollment of the first patient in a phase 2b, randomised, partially-blinded, multi-center, active-controlled, dose-ranging study of its product candidate, the REG1 anticoagulation system (REG1).

REG1 comprises the selective factor IXa inhibitor, RB006, and its specific active control agent, RB007. The trial, called RADAR, will assess the safety, efficacy, and pharmacodynamics of REG1 compared to unfractionated heparin or low molecular weight heparin in subjects with acute coronary syndromes (ACS).

Reportedly, the primary objectives of RADAR will be to determine the clinically acceptable dose range of the specific active control agent, RB007, which can be used to reliably partially or totally reverse the anticoagulant effect of RB006 while reducing bleeding in comparison to heparin.

The study will also determine the pharmacodynamics of the REG1 anticoagulation system in subjects intended for cardiac catheterization within 24 hours who are admitted for ACS-unstable angina and myocardial infarction without ST-segment elevation (UA/NSTEMI).

Steven Zelenkofske, chief medical officer of Regado, said: “We are very excited to report the first patient being enrolled in the RADAR study. This event marks a key milestone in the development of this innovative anticoagulation system with its simple yet elegant approach to balancing concomitantly risk reduction of ischemia and bleeding.”