REG1 Anticoagulation System: Phase IIb data

The double-blind reversal, active-controlled, international Phase IIb RADAR trial in 640 evaluable ACS patients undergoing cardiac catheterization showed that Regado's REG1 Anticoagulation System met 1 of 2 co-primary endpoints. On the first co-primary endpoint, the arm consisting of 100% reversal of Factor IXa inhibition significantly reduced the rate of total ACUITY bleeding at 30 days vs. the 25% reversal arm (30.4% vs. 65%, p<0.0001). The 100% arm consisted of 1 mg/kg IV pegnivacogin followed by 1 mg/kg IV anivamersen, while the 25% reversal arm consisted of a 0.075 mg/kg dose of IV anivamersen. On the second co-primary endpoint, 1 mg/kg IV pegnivacogin followed by 1 mg/kg IV anivamersen non-significantly reduced the rate of total ACUITY bleeding at day 30 vs. unfractionated heparin or low molecular weight heparin (30.4% vs. 31.3%, p=0.9). ...