Print 20 Декабря 2012
New Investor Leads Round to Fund Phase 3 Development of REG1
Basking Ridge, NJ – December 19, 2012 — Regado Biosciences, Inc., a privately held company leading the development of antithrombotic aptamers with active control agents, announced it has secured a landmark $51 million Series E financing. The round was led by new investor RusnanoMedInvest, a subsidiary of the state-run Russian investment firm RUSNANO, and included participation from another new, US-based investor, Baxter Healthcare’s venture initiative, Baxter Ventures. Existing investors Edmond de Rothschild Investment Partners, Domain Associates, Quaker Partners, Aurora Funds and Caxton Advantage Life Sciences Fund also participated in the round.
“We are proud to say this financing is among the largest private rounds to be completed in 2012,” said David J. Mazzo, PhD, President and CEO of Regado. “We welcome new investors RusnanoMedInvest and Baxter Ventures as we advance REG1 into Phase 3 development. We also thank our existing investors for their continued confidence in our execution strategy and shared enthusiasm for uncovering REG1’s full potential. We believe the magnitude of this investment and our continued ability to attract new investors is a testament to the outstanding clinical results and potential game-changing therapeutic value we have demonstrated to date for REG1.”
Proceeds from the financing will support Regado’s “REGULATE – PCI” Phase 3 clinical study of REG1. This is the company’s lead development program for REG1 in arterial thrombosis and is being developed for use in percutaneous coronary intervention (PCI) in the acute coronary syndrome (ACS) population. Regado is also pursuing an additional parallel development program for REG1 for use in Open Heart Surgery. While the vast majority of the funding will be used for the Phase 3 development of REG1 for PCI, some funding will be used to advance other development programs in the Regado pipeline such as REG1 for TAVI (transaortic valve implantation) and REG3 in diabetic vasculopathy.
In the completed Phase 2b RADAR clinical study, REG1 demonstrated nearly complete Factor IXa inhibition with a dose of 1 mg/kg of pegnivacogin and, when followed by reversal with anivamersen, resulted in dose-dependent reduction in both the rate of major bleeding events and the incidence of ischemic events when compared to patients treated with heparin. REG1’s Phase 2b results show trends which may indicate significant pharmacoeconomic benefits, including improved administration convenience, faster onset of action, instantaneous reversal, immediate sheath pull at the end of the PCI procedure, faster patient ambulation, reduced need for closure devices, improved facility and staff efficiency and better overall outcomes.
Dr. Mazzo concluded, “The groundbreaking data from our Phase 2b RADAR study strengthened our belief that REG1 is the only anticoagulant available or in development that can simultaneously decrease the incidence of ischemic and bleeding events associated with PCI in the ACS population. Given that the Phase 3 REGULATE-PCI program will resemble the Phase 2b in subject population, endpoints, dosing and duration of follow-up, we fully expect to confirm REG1’s superior profile and paradigm-changing potential pertaining to the way anticoagulation is practiced in the acute care setting.”
About REGULATE – PCI
The Phase 3 program was designed based on the advice of leading physicians active in the development of anticoagulants for PCI and information obtained at a successful end-of-Phase 2 meeting with FDA. It will consist of a single, mortality/morbidity study of REG1 that will examine standard ischemic efficacy, including all cause death, stroke, non-fatal myocardial infarction (MI) and urgent TVR, and safety (major bleeding) endpoints. Pharmacoeconomic indicator endpoints will also be examined. Patients will be enrolled at ~500 sites worldwide with enrollment expected to complete 24 months after initiation.
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 and concomitantly minimizing the risk of ischemia and bleeding, and, by allowing patient specific tuning of the desired therapeutic effect, provide a safe and unique approach to personalized medicine.
ABOUT REG1, REG2 and REG3
Regado’s lead program, the anticoagulant system REG1, consists of two agents both administered by IV bolus, the first being a potent highly selective Factor IXa inhibitor (pegnivacogin) with the second being its complementary active control agent (anivamersen). Anivamersen can be used to selectively reverse (completely or partially) the anticoagulant effect of pegnivacogin. REG1, poised to begin Phase 3 following a successful Phase 2b trial (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 has 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. 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 during 2013 with an initial target indication of treating diabetic vasculopathies.
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 complementary specific active control agent of pegnivacogin.
More information can be found at www.regadobio.com
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