Regado completes enrollment in Phase IIa study of anticoagulation system

REG1 is a two-component system composed of an aptamer-based anticoagulant, RB006, and its matched, active reversal agent, RB007, which specifically binds to and neutralizes RB006.

The Phase IIa study (Reversal-PCI) is designed to assess whether REG1 can replace standard heparin therapy during the performance of coronary balloon angioplasty dilatation and stenting on patients at low risk for complications associated with therapy-related bleeding or heart attack.

Reversal-PCI, a multi-center, open-label, randomized clinical study, has enrolled a total of 26 patients. All patients were pre-treated with clopidogrel and aspirin to inhibit platelet activity and were then randomized to receive either REG1 or unfractionated heparin. In patients treated with the REG1 system, RB006 was used as the sole anticoagulant during the procedure.

Following the procedure, RB007 was used to reverse the effects of RB006 with the goal of facilitating early sheath removal. Primary procedural success in the trial is defined by the absence of significant bleeding events up to hospital discharge or 48 hours post stenting, and by the absence of death, nonfatal heart attack, or need to repeat revascularization up to day 14.

David Mazzo, president and CEO of Regado Biosciences, said: “The Phase IIa trial is designed to build on extensive Phase I results demonstrating, among other things, that RB006 safely and effectively inhibited the activity of factor IXa, an essential blood clotting protein, and that RB007 rapidly, safely and specifically reversed the activity of RB006. We are pleased to have reached this milestone in our clinical program and look forward to continued progress in the coming months.”