Regado Biosciences, Inc. Presents Results of the RADAR Phase 2b Clinical Trial of its REG1 Anticoagulation System
BASKING RIDGE, N.J., April 3, 2011 /PRNewswire/ -- Regado Biosciences, Inc., a privately held company pioneering the development of antithrombotic aptamers with active control agents, announced today the primary results of the RADAR Phase 2b clinical trial of the company's lead product, the anticoagulation system REG1, at the i2 Summit during the American College of Cardiology 2011 60th Annual Scientific Session & Expo in New Orleans, LA. REG1 is a two-component system consisting of pegnivacogin, a highly selective Factor IXa (FIXa) inhibitor and anivamersen, its complementary specific active control agent.
The presentation, "A Randomized, Partially-Blinded, Multi-Center, Active-Controlled, Dose-ranging Study Assessing the Safety, Efficacy and Pharmacodynamics of the REG1 Anticoagulation System Compared to Unfractionated Heparin or Low Molecular Weight Heparin in Subjects with Acute Coronary Syndromes: Primary Results of the RADAR Randomized Clinical Trial," was made by Thomas J. Povsic, MD, PhD, Assistant Professor of Medicine at Duke University during an i2 Special Session titled "Interventional Featured Clinical Studies I."
The international Phase 2b RADAR clinical trial was conducted in subjects admitted for ACS-unstable angina and myocardial infarction without ST-segment elevation (UA/NSTEMI) intended for cardiac catheterization within 24 hours. The objectives of RADAR were to verify that 1 mg/kg of pegnivacogin resulted in near complete FIXa inhibition, to determine the dose of anivamersen which, when followed by immediate arterial sheath removal, results in a bleeding rate lower than heparin and to assess the efficacy of REG1 (based on ischemic event rates) as an anticoagulant system in an invasively managed ACS population. The primary endpoint of the study was ACUITY bleeding (major and minor) at 30 days. A secondary endpoint was