About Regado

OVERVIEW

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. 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.

Regado is focusing its discovery and development efforts on 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. 

The REG1 Anticoagulation System, Regado’s lead product candidate, consists of:

  • RB006, a pegylated aptamer anticoagulant that specifically inhibits Factor IXa, a protein critical to blood coagulation, and
  • RB007, the Watson-Crick base-pair complement of a segment of RB006 that acts as a specific control agent for RB006.

REG1 is being developed for use in patients suffering from acute coronary syndrome (ACS), including those who undergo coronary revascularization procedures, which include percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG).  These procedures put patients at risk for therapy-related bleeding complications.  REG1 is designed to increase therapeutic flexibility for physicians while reducing side effects and improving outcomes experienced by patients in this setting.

The REG1 Phase 1 clinical program, which consisted of three studies that enrolled more than 170 individuals, established REG1 was well-tolerated, exhibited predictable pharmacokinetics and demonstrated the anticipated pharmacodynamic effects in both healthy volunteers and patients with cardiovascular disease.  Click here for results from the Phase 1 studies.  The Company recently completed a multi-center, open-label, randomized Phase 2a clinical trial of REG1 in 26 patients undergoing elective PCI (REVERSAL-PCI).  This study demonstrated that REG1 enabled safe and effective PCI and permitted the planned early removal of the arterial catheter sheath without any ischemic or bleeding complications.  Click here for results from the REVERSAL-PCI study.   Currently, the Company is enrolling patients in its rigorous Phase 2b program for REG1, the RADAR study.  This large, multi-center, active contolled, dose ranging study of RB007 used in concert with a fixed 1 mg/kg dose of RB006 will enroll 800 patients.  More details about the RADAR trial can be found at:  www.clinicaltrials.gov

Recently, Regado has initiated a Phase 1 trial using a subcutaneous formulation of RB006 paired with an IV bolus formulation of RB007 for eventual application in venous thrombosis indications.  Additionally, the company is conducting discovery efforts to identify an aptamer:control agent pair for clinical study as an antiplatelet therapy.

Intellectual property covering Regado’s technology derives from work originating at Duke University Medical Center's Division of Surgical Sciences and is licensed exclusively to Regado.  Regado is building upon the platform nature of its technology, developing a pipeline of aptamers and their complementary control agents.

Founded in 2003, Regado is a privately held company with support from leading healthcare venture capital investors:  Domain Associates, Quaker BioVentures, Edmond deRothschild Investment Partners, Aurora Funds and Caxton Advantage Life Sciences Fund.