Regado Biosciences to commence Phase I study of a subcutaneous administration formulation of the REG1 anticoagulation system

Regado Biosciences, Inc, a privately held company leading the development of antithrombotic therapeutic aptamers with active control agents, today announced enrollment of the first patient in the first Phase I study of a subcutaneous administration formulation of the REG1 anticoagulation system. The study is a double-blind, randomized, placebo-controlled, single ascending dose study to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of RB006 administered subcutaneously, with and without intravenously administered RB007, in healthy adult volunteers. REG1 is a two component system composed of RB006, a specific and direct inhibitor of Factor IXa, and RB007, the specific controlling agent that reverses RB006. To date, this will be the first known use of an aptamer in humans delivered by the subcutaneous route of administration. Recently, Regado successfully completed a phase 2a study of intravenously administered REG1 in stable coronary artery disease patients undergoing elective PCI.

This Phase 1 study will have three primary objectives. First, it will determine the pharmacokinetics, bioavailability and pharmacodynamics of subcutaneous administered RB006. Second, it will determine the safety and tolerability of subcutaneous administered RB006 and third, it will determine the impact of intravenous administered RB007 on the pharmacokinetics, bioavailability and pharmacodynamics in subjects who received subcutaneous administered RB006. The study will enroll a total of 32 subjects.

Dr. Steven L. Zelenkofske, Chief Medical Officer of Regado Biosciences stated, "This is an important milestone in expanding the possible applications of the REG1 system." David J. Mazzo, PhD., President and CEO of Regado Biosciences, added, "The introduction of subcutaneously administered REG1 promises to bring an unprecedented level of individual specific control and flexibility to the physician caring for patients in need of chronic anticoagulant therapy."