Regado Presents Positive Data From REG1 Anticoagulation System Study
REG1 Anticoagulation System
Regado Biosciences presented data from a randomized, double-blind, placebo-controlled Phase Ic study of REG1 Anticoagulation System. REG1 is a two-component system comprised of an aptamer-based anticoagulant, RB006, and its matched antidote, RB007, which binds to and neutralizes RB006. The study results support RB007's ability to reverse the anticoagulant effect of RB006 either completely or partially, depending on the level of dosing of RB007. Consistent with previously reported Phase I results, these data were presented by the Duke Clinical Research Institute at the American Heart Association's 2007 Scientific Sessions, currently being held in Orlando, Florida.
Clinical researchers from the Duke Clinical Research Institute and Regado randomized 39 healthy volunteers to receive either three consecutive REG1 treatment cycles or placebo. Each REG1 cycle consisted of an intravenous (IV) bolus of RB006 dosed at 0.75 mg/kg, followed an hour later by a descending dose of RB007, ranging from a 2:1 to 0.125:1 antidote:drug ratio (1.5 mg/kg to 0.094 mg/kg of RB007). Clinical and coagulation assessments were measured for 14 days.
The study showed repeated doses of RB006 achieved highly reproducible increases in activated partial thromboplastin time (aPTT), a well-accepted surrogate marker of the blood's ability to clot. Subsequently, repeat doses of RB007 reversed the aPTT levels dose-dependently and reproducibly. There were no major bleeding episodes or other serious adverse events reported in this study.
"I am encouraged by RB007's activity to date in reversing or neutralizing the anticoagulant effect of RB006, either completely or partially, as needed. The potential to modulate coagulation quickly based on the patient's condition represents an advance in anticoagulation therapy that could advance clinical care," said Robert A. Harrington, M.D., Professor of Medicine, Duke University Medical Center, and Director, Duke Clinical Research Institute. "I'm looking forward to seeing data from phase II and phase III studies with the REG1 drug:antidote system."
"The data from the Phase 1c study addressed important questions, particularly regarding the ability to titrate the RB007 component and therefore 'dial down' the anticoagulant effect of RB006," stated Doug Gooding, Chief Executive Officer of Regado Biosciences. "Based upon our Phase I study results, we developed an extensive Phase II program to evaluate REG1 in a variety of coronary revascularization settings. The first study is actively enrolling patients and we expect to initiate several additional studies over the coming months."
REVERSAL-PCI, a multi-center, open-label, randomized Phase IIa clinical study of the REG1 anticoagulation system, will enroll 26 patients undergoing elective percutaneous coronary intervention (PCI) to assess whether REG1 can replace standard heparin therapy during the performance of coronary balloon angioplasty dilatation and stenting in patients at low risk for complications associated with therapy-related bleeding or heart attack.