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Clinical researchers from the Duke Clinical Research Institute and Regadorandomized 39 healthy volunteers to receive either three consecutive REG1treatment 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 descendingdose of RB007, ranging from a 2:1 to 0.125:1 antidote:drug ratio (1.5 mg/kg to0.094 mg/kg of RB007). Clinical and coagulation assessments were measured for14 days.
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The study showed repeated doses of RB006 achieved highly reproducibleincreases in activated partial thromboplastin time (aPTT), a well-acceptedsurrogate marker of the blood's ability to clot. Subsequently, repeat dosesof RB007 reversed the aPTT levels dose-dependently and reproducibly. Therewere no major bleeding episodes or other serious adverse events reported inthis study.
"I am encouraged by RB007's activity to date in reversing or neutralizingthe anticoagulant effect of RB006, either completely or partially, as needed.The potential to modulate coagulation quickly based on the patient's conditionrepresents an advance in anticoagulation therapy that could advance clinicalcare," said Robert A. Harrington, M.D., Professor of Medicine, Duke UniversityMedical Center, and Director, Duke Clinical Research Institute. "I'm lookingforward to seeing data from phase II and phase III studies with the REG1drug:antidote system."
"The data from the Phase 1c study addressed important questions,particularly regarding the ability to titrate the RB007 component andtherefore 'dial down' the anticoagulant effect of RB006," stated Doug Gooding,Chief Executive Officer of Regado Biosciences. "Based upon our Phase I studyresults, we developed an extensive Phase II program to evaluate REG1 in avariety of coronary revascularization settings. The first study is activelyenrolling patients and we expect to initiate several additional studies overthe coming months."
REVERSAL-PCI, a multi-center, open-label, randomized Phase IIa clinicalstudy of the REG1 anticoagulation system, will enroll 26 patients undergoingelective percutaneous coronary intervention (PCI) to assess whether REG1 canreplace standard heparin therapy during the performance of coronary balloonangioplasty dilatation and stenting in patients at low risk for complicationsassociated with therapy-related bleeding or heart attack.
About REG1 Anticoagulation System
Regado's lead product candidate, REG1, is the first specific, direct-acting, antidote-controlled anticoagulant ever described. Regado isdeveloping REG1 for use in patients suffering from acute coronary syndrome whoundergo coronary revascularization procedures. These procedures, whichinclude coronary artery bypass grafting (CABG) and percutaneous coronaryintervention (PCI), put patients at a high-risk for therapy-related bleedingcomplications. REG1 is being developed initially to increase therapeuticflexibility and improve patient outcomes in coronary revascularizationprocedures.
REG1 is a two-component system, consisting of an aptamer-basedanticoagulant and its matched antidote. The REG1 anticoagulant component(RB006) is a single-stranded, nucleic ac
