Regado Biosciences Releases Positive Phase 2a Data For The Reversible Anticoagulant System Reg1 At The European Society Of Cardiology Congress In Barcelona, Spain
Basking Ridge, NJ - August 31, 2009 - Regado Biosciences, a privately held company leading the development of antithrombotic aptamers with active control agents, announced today that the results of a Phase 2a clinical trial of their lead product, the anticoagulant system REG1, were released at the European Society of Cardiology Congress in Barcelona, Spain. The results, detailed in a poster entitled, "First Clinical Application of an Actively Reversible Direct Acting Factor IXa inhibitor in Elective Percutaneous Intervention", were presented by Dr. Mauricio Cohen, lead investigator of the study from the University of Miami-Miller School of Medicine. The poster was presented on Sunday, August 30, 2009.
This was the first study to evaluate REG1 in a clinical setting involving percutaneous coronary intervention (PCI). REG1 is a two component system consisting of RB006, a direct FIXa inhibitor and RB007, the active, specific control agent for RB006. This phase 2a study (REVERSAL-PCI) was an open-label, randomized, multicenter study that evaluated feasibility and safety during elective PCI comparing the REG1 anticoagulant system with unfractionated heparin in patients with coronary artery disease. All 26 patients in the study received aspirin and clopidogrel as background therapy. The primary endpoint of the study was major bleeding within 48 hours. Important secondary endpoints were a composite of death, myocardial infarction or urgent target vessel revascularization within 14 days and pharmacodynamic measures. The three arms of the study were designed to measure both total and partial anticoagulant reversal, with all REG1 subjects undergoing planned early arterial catheter sheath removal.
The study demonstrated that the REG1 System enabled safe and effective PCI. All procedures were successfully completed in the REG1 cohorts with no signs of catheter or guidewire thrombosis. Coagulation parameters demonstrated effective, predictable and consistent ranges of anticoagulation during the study. Reversal of the anticoagulant effects of RB006 using RB007 was rapid, predictable and reproducible and permitted planned early arterial catheter sheath removal. The study also demonstrated that REG1 was well tolerated during PCI.
"The REVERSAL-PCI study represents the first study in which a reversible aptamer anticoagulation system was employed during an interventional cardiology procedure. These results demonstrate the potential for the use of the REG1 S-system in patients undergoing PCI", stated Dr Mauricio Cohen, the principle investigator for the study.
"This first clinical application of the REG1 System in PCI is a significant milestone in the development of this innovative and unique product. Based on these positive results, we can confidently advance to the next stage of development with the initiation of the ‘RADAR' trial, our phase 2b study", stated Chris Rusconi, PhD, Chief Scientific Officer and Co-Founder of Regado Biosciences. President and CEO David J. Mazzo, PhD added, "We are delighted and honored to have the REVERSAL-PCI data accepted and presented at such a prestigious meeting as the European Society of Cardiology Congress".
ABOUT REGADO BIOSCIENCES: Regado Biosciences is pioneering a new therapeutic technology with the creation and development of two-component drug systems. Each system comprises a nuclease-stabilized RNA aptamer that can be controlled directly by its specific and complementary oligonucleotide active control agent. This technology is being applied to injectable antithrombotics, including anticoagulants and antiplatelet agents, a multi-billion dollar market in need of therapeutics with improved safety profiles and a greater degree of therapeutic control. Regado's technology is designed to give physicians the ability to actively and directly control each system's therapeutic effect providing a safe and unique approach to personalized medicine.
ABOUT THE REG1 SYSTEM: Regado's lead program, the anticoagulant system REG1, consists of two parenteral agents, the first being a potent and highly selective Factor IXa inhibitor (RB006) and the second being its complementary active control agent (RB007). RB007 can be used to selectively completely or partially reverse the anticoagulant effect of RB006.
ABOUT APTAMERS: RB006 is a member of a class of compounds called aptamers. Aptamers are single stranded oligonucleotides that adopt a specific conformation enabling direct, specific inhibition of the targeted protein. A key unique feature of aptamers derives from the fact that they are formed from nucleic acids. As such, their pharmacologic activity can be controlled by a matched, complementary oligonucleotide active control agent (the Watson-Crick base pair complement of a fraction of the agent to be controlled), which can bind to the aptamer, removing it from its target and reversing it biologic effects.