Regado Biosciences, Inc. Presents Pharmacokinetic and Pharmacodynamic (PK/PD) Substudy Results From its Phase 2b RADAR Trial at the American Heart Association (AHA) Scientific Sessions 2010 Meeting
BASKING RIDGE, N.J., Nov. 16, 2010 /PRNewswire/ — Regado Biosciences, Inc., a privately held company leading the development of antithrombotic aptamers with active control agents, announced that Thomas J. Povsic, MD, Ph.D., Duke University Medical Center, presented an abstract at the AHA Scientific Sessions meeting on November 16, 2010 at 10:45 a.m. CST in Chicago, IL.
The abstract, entitled “RB006, a Direct Factor IX Inhibitor Results in Consistent and Near Complete Inhibition of Factor IX in Patients with Acute Coronary Syndromes: A RADAR Pharmacokinetic and Pharmacodynamic Substudy,” evaluated the appropriateness of the selected dose of pegnivacogin (a.k.a. RB006) for use in patients with Acute Coronary Syndromes. RB006 is part of the REG1 anticoagulation system.
Regado’s ongoing Phase 2b clinical trial titled: “Randomized, Partially-Blinded, Multi-Center, Active-Controlled, Dose-Ranging Study Assessing the Safety, Efficacy, and Pharmacodynamics of the REG1 Anticoagulation System Compared to Unfractionated Heparin or Low Molecular Heparin in Subjects with Acute Coronary Syndrome,” (a.k.a. RADAR) is a partially blinded study currently enrolling 800 patients in more than 90 centers worldwide. Patients were randomly allocated [4:1] to receive open-label RB006 or unfractionated heparin prior to catheterization and underwent various levels of double blind reversal at the end of the procedure. This substudy, conducted in the open label portion of RADAR, included thirty patients, 20 of whom had not received recent unfractionated heparin. It assessed PK/PD measurements just prior to and 10 minutes after dosing with RB006. PK/PD assessments were also made, both prior to and after cardiac catheterization and before blinded dosing of anivamersen (a.k.a. RB007), RB006′s complementary active control agent. The objective was to evaluate the appropriateness of the selected RB006 dose.
The data from this abstract demonstrated that RB006 (1mg/kg, IV) results in consistent and near complete inhibition of FIX in patients with ACS with stable anti-coagulation throughout catheterization (PCI). These findings further validate the dosing of RB006 for Regado’s ongoing and planned clinical trials.
The abstract is coauthored by Thomas J. Povsic, MD, Ph.D., Richard A. Becker, MD, and John H. Alexander, MD, MHS, all from Duke University Medical Center; Christopher P. Rusconi, Ph.D., Steven L. Zelenkofske, D.O., both from Regado Biosciences; and William Wargin, Ph.D., President of PK-PM Associates, LLC; Mauricio G. Cohen, MD, University of Miami Miller School of Medicine; Roxana Mehran, MD, Mount Sinai School of Medicine; Christoph Bode, MD, University of Freiburg, Germany; Joshua Krasnow, MD, Heart Center Research, LLC; and Merrill Krolick, D.O., Heart and Vascular Institute of Florida.
ABOUT REGADO BIOSCIENCES
Regado Biosciences, Inc. is a private biopharmaceutical company pioneering a new therapeutic technology with the creation and development of proprietary controllable aptamer drug systems. Each system comprises a nuclease-stabilized RNA aptamer, the therapeutic effect of which can be reversed partially or completely in real time 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 cardiovascular setting, a multi-billion dollar world-wide market in need of drugs with improved safety profiles and a greater degree of therapeutic control. The products in Regado’s pipeline are designed to act as optimized antithrombotics, uniquely concomitantly minimizing the risk of ischemia and bleeding, and, by allowing patient specific tuning of the desired 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 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. Anivamersen is the active control agent of pegnivacogin.
More information can be found at www.regadobio.com.
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