Regado Biosciences Announces Publication in the American Heart Association Journal Circulation of the results of a Phase 2a Study for the REG1 Anticoagulant System in Elective Percutaneous Interventions
Basking Ridge, NJ — July 26, 2010 — Regado Biosciences, Inc., a privately held biopharmaceutical company pioneering the development of a novel two-component antithrombotic drug technology consisting of therapeutic aptamers with their matched active control agents, announced publication of results from a Phase 2a study for its lead compound, the REG1 system. The study is known as REVERSAL-PCI. The company’s REG1 technology, a selective coagulation factor IXa inhibiting aptamer (pegnivacogin, a.k.a. RB006) and its matched active control agent (anivamersen, a.k.a. RB007), is the first of its kind to enter clinical testing. The results are published in the American Heart Association journal Circulation under the title, “First Clinical Application of an Actively Reversible Direct Factor IXa Inhibitor as an Anticoagulation Strategy in Patients Undergoing Percutaneous Coronary Intervention.” REVERSAL-PCI was a phase 2a, open-label, multicenter, randomized study comparing REG1 with unfractionated heparin (UFH) during elective percutaneous coronary intervention (PCI). The full text of the study is available at http://circ.ahajournals.org.
The primary outcome measures of the study were major bleeding within 48 hours or through hospital discharge, whichever occurred first, and a composite of all-cause death, nonfatal myocardial infarction (heart attack), and urgent target vessel revascularization within 14 days. The study demonstrated that early sheath removal can be performed safely after PCI without an excess in bleeding. REG1 demonstrated nearly complete factor IXa inhibition, achieved with a single intravenous RB006 bolus without thrombotic complications, a finding that has not been previously documented. Partial reversal of RB006 using RB007 allowed for a graded or “controlled stepdown” in anticoagulation.
The trial's lead investigator, Mauricio G. Cohen, MD, Associate Professor of Medicine and Director of the Cardiac Catheterization Laboratory of the University of Miami Miller School of Medicine, stated, “We are highly encouraged by the results of this study as it appears the REG1 system may potentially offer physicians a unique method of truly controlling anticoagulation. The holy grail of anticoagulant therapy is to achieve the delicate balance of minimizing the risk of ischemic complications while concomitantly minimizing the risk of bleeding. Based on the results of this study, controlled anticoagulation is possible with the REG1 system.”
The authors conclude that conduct of elective PCI is feasible and well tolerated with REG1. An anticoagulation strategy employing factor IXa inhibition with pegnivacogin followed by an active reversal strategy utilizing anivamersen may provide for an optimized balance between safety and efficacy during PCI, wherein a period of heightened thrombotic potential coexists with a need for effective hemostasis.
David J. Mazzo, Ph.D., President and CEO of Regado Biosciences, Inc., commented, “As the data confirms, Regado moves one step closer to solving the antithrombotic conundrum that has challenged physicians since the first anticoagulant therapy was developed more than 75 years ago. It is readily accepted that the consequences of adverse ischemic events are severe and potentially grave, but as recently published study results show, the medical and pharmacoeconomic consequences of adverse bleeding events are equally serious. Simultaneously minimizing risk of ischemia and bleeding is a unique characteristic of REG1 and positions it to become the benchmark in optimized anticoagulant therapy.”
“Given the encouraging results reported in this study, we look forward to equally positive results of the phase 2b clinical trial of REG1 (RADAR) in ACS-PCI and to the clinical advancement of the other compounds in the Regado pipeline.”
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) in the acute and sub-acute care setting, 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 REG1, REG2 and REG3
Regado’s lead program, the anticoagulant system REG1, consists of two parenteral agents both administered by IV bolus, the first being a potent highly selective Factor IXa inhibitor (pegnivacogin, a.k.a. RB006) and the second being its complementary active control agent (anivamersen, a.k.a. RB007). Anivamersen can be used to selectively completely or partially reverse the anticoagulant effect of pegnivacogin. REG1, presently in a phase 2b clinical trial (the RADAR trial), is intended for application in arterial thrombosis applications, initially in Acute Coronary Syndrome patients intended for Percutaneous Coronary Intervention. A clinical program in Open Heart Surgery [including coronary artery bypass grafting (CABG) and valve repair/replacement] is also under development. REG2, Regado’s second product candidate, consists of a subcutaneously administered depot formulation of pegnivacogin paired with the IV bolus formulation of anivamersen. REG2 recently completed single escalating dose phase 1 clinical testing (the first successful subcutaneous application of an aptamer in humans) and is planned to be studied in a multiple escalating dose clinical trial in late 2010 or early 2011. It is intended for use in venous thrombosis indications such as venous thromboembolism (VTE) prophylaxis in patients undergoing abdominal surgery. REG3, Regado’s third program, consists of a specific GPVI inhibitor and its active control agent (RB571 and RB515, respectively). REG3 is planned to enter phase 1 human clinical testing in 2011 and will be indicated for antiplatelet therapy. Information pertaining to Regado’s clinical programs may be obtained at www.clinicaltrials.gov.
Pegnivacogin 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 its biologic effects.
More information can be found at www.regadobio.com