- Phase 1b Study is First to Show RNA Aptamer Drug:Antidote Pair Offers Rapid Reversal of Anticoagulant Effect in Patients with Coronary Artery
DURHAM, N.C., June 5 /PRNewswire/ -- Regado Biosciences today announced the journal Circulation has published clinical data from the Company's REG1 anticoagulation system Phase 1b dose-escalation study. 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 published study is the first to show in patients that RB006 effectively inhibited the activity of Factor IXa, a protein essential to blood clotting and that RB006's activity was reversed rapidly and safely by RB007.
The article, titled, "A Phase 1b Randomized Study of Antidote-Controlled Modulation of Factor IXa Activity in Patients with Stable Coronary Artery Disease", was authored by clinical researchers from the Duke Clinical Research Institute and Regado. The study showed an intravenous (IV) bolus injection of RB006 achieved a prompt, consistent, and dose-dependent prolongation of activated partial thromboplastin time (aPTT), a well-accepted surrogate marker of the blood's ability to clot. In addition, a 1 mg/kg dose of RB006 resulted in essentially complete Factor IXa inhibition. The study also demonstrated an IV bolus injection of RB007 administered in a 2:1 antidote:drug ratio successfully reversed prolonged aPTT within a median of one minute, with no rebound for up to seven days. There were no major bleeding or other serious adverse events observed in the study, which included 19 subjects who received dual antiplatelet therapy.
"The data published in Circulation provide further evidence of the REG1 system's ability to rapidly and predictably anticoagulate and then to reverse this effect as needed in a reproducible manner. The results also show the pharmacologic data translated well from healthy volunteers to the CAD patient population," stated Doug Gooding, Chief Executive Officer of Regado Biosciences. "Following the completion of a Phase 1 program in a total of 173 patients, the Company now is evaluating this first-in-class antidote-reversible therapeutic system in a Phase 2a trial in patients undergoing elective percutaneous coronary intervention. If the results of this study further confirm the Phase 1 data, we are confident this system may be able to transform the way anticoagulation is approached in coronary revascularization procedures and other acute care settings."
Data from Regado's Phase 1b study were presented previously at the American Heart Association's 2007 Scientific Sessions.
About REG1 Anticoagulation System Clinical Program
Regado's Phase 1 program included three studies. A Phase 1a study enrolled 84 healthy volunteers, while the Phase 1b study reported above enrolled 50 patients with stable coronary artery disease who were receiving aspirin with or without clopidogrel. In addition, the Company conducted a Phase 1c clinical study, in which 39 healthy volunteers were randomized to receive either three consecutive REG1 treatment cycles or placebo. The Phase 1c study further demonstrated RB007's ability to reverse the anticoagulant effect of RB006 either completely or partially, depending on the level of dosing of RB007.
Based upon the combined results of the Company's Phase 1a, 1b, and 1c studies, Regado initiated REVERSAL-PCI, a multi-center, open-label, randomized Phase 2a clinical study of the REG1 anticoagulation system. The Phase 2a study is enrolling 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.
About REG1 Anticoagulation System
Regado's lead product candidate, REG1, is the first specific, direct-acting, antidote-controlled anticoagulant ever described. Regado is developing REG1 for use in patients suffering from acute coronary syndrome who undergo coronary revascularization procedures. These procedures, which include coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI), put patients at a high-risk for therapy-related bleeding complications. REG1 is being developed initially to increase therapeutic flexibility and improve patient outcomes in coronary revascularization procedures.
REG1 is a two-component system, consisting of an aptamer-based anticoagulant and its matched antidote. The REG1 anticoagulant component (RB006) is a single-stranded, nucleic acid aptamer. RB006 selectively and potently binds to and inhibits Factor IXa, a protein that is critical to blood coagulation. The antidote component, RB007, is a complementary nucleic acid that binds to and neutralizes RB006. The binding of RB007 to RB006 causes the predictable and rapid reversal of RB006 that allows the patient's blood to return to normal.
About Regado Biosciences
Regado Biosciences is pioneering a new therapeutic field with the discovery and development of drug:antidote systems. Regado's drug:antidote systems are designed to give physicians the ability to fine-tune the therapeutic effect desired for each patient and in each setting. A spin-out of the Department of Surgery at Duke University Medical Center, Regado was created to answer the therapeutic needs identified by its scientific founders.
The Company's proprietary platform technology enables the discovery of oligonucleotide-based drug-antidote pairs to any target protein. Regado initially is focusing its discovery and development efforts on the acute care injectable antithrombotics, a multi-billion dollar market in need of therapeutics with improved safety profiles. Potential future indications for Regado's technology include acute coronary syndromes and other coronary revascularization procedures that would benefit from the availability of an antidote-reversible agent.
|SOURCE Regado Biosciences|
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