Regado Biosciences, Inc. Presents Three Abstracts Pertaining to its Pipeline of Reversible Antithrombotic Agents, Including the Substudy Analyses of its Phase 2b RADAR Trial for REG1, its Lead Product Candidate, at the American Heart Association (AHA) Scientific Sessions 2011 Meeting
BASKING RIDGE, N.J., Nov. 14, 2011 /PRNewswire/ -- Regado Biosciences, Inc., a privately held company leading the development of antithrombotic aptamers with active control agents, announces one poster presentation and two oral presentations at the American Heart Association (AHA) Scientific Sessions meeting on November 14, 2011 during the 9:00 a.m. – 5:00 p.m. EST session. All three presentations highlight results from Regado's pipeline of antithrombotic agents for the treatment of cardiovascular disease.
Ingo Ahrens, M.D., of University Hospital in Freiburg, Germany, presented "REG1, a Novel RNA-Aptamer Direct Factor IXa-inhibitor Reduces Platelet Activation in Healthy Volunteers and Residual Platelet Aggregation in Patients with ACS. A RADAR Substudy," at 10:45 a.m. EST. John Vavalle, M.D., a Fellow in the Division of Cardiology at the Duke University Medical Center, presented further RADAR substudy results in an Abstract Oral Session at 11:15 a.m. EST with a poster titled "The REG1 Anticoagulation System Allows for Early Arterial Sheath Removal After Cardiac Catheterization Without Increases in Time to Hemostasis or Bleeding Complications: An Analysis From the RADAR Clinical Trial."
The above referenced presentations offer substudy analyses of the Company's Phase 2b RADAR clinical trial of REG1, Regado's proprietary anticoagulation system. The RADAR results demonstrated that REG1 provided nearly complete Factor IXa inhibition with a dose of 1 mg/kg of pegnivacogin and, when followed by 75% and 100% reversal doses of anivamersen, resulted in numerically lower rates of ischemic events when compared with heparin. The RADAR results clearly support the progression of the development of REG1 to phase 3.
Dr. Vavalle also presented "Thrombin Generation Kinetics of the REG2 Anticoagulation System: A First-in-Human Experience" at 3 p.m. EST during an Abstract Poster Session. REG2 is Regado's second product candidate, which consists of a subcutaneously administered formulation of the specific Factor IXa inhibitor, pegnivacogin, (a.k.a. RB006), paired with an IV bolus formulation of its complementary active control agent, anivamersen, (a.k.a. RB007). REG2 is anticipated to provide a favorable therapeutic profile with a slow onset of action and duration of effect lasting several days, ideally suited for venous thrombosis indications.
"Presenting such positive REG1 and REG2 data to an audience of industry peers at AHA validates the potential of Regado's science and pipeline," said David J. Mazzo, PhD, President and CEO of Regado. "The RADAR trial results further demonstrate REG1's ability to promote early arterial sheath removal after cardiac catheterization without increasing time to hemostasis. We believe this data provides additional validation of REG1's favorable profile as the only truly reversible anticoagulant in development."
"REG2 has also demonstrated significant potential for application in venous thrombosis indications, which is a commentary on our strong pipeline," Dr. Mazzo continued.
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, having recently completed phase 2b clinical development (the RADAR trial), is intended for application in arterial thrombosis indications, such as Acute Coronary Syndrome patients undergoing 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.
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