FDA accepts Regado Biosciences' IND application for REG2

Regado Biosciences, Inc. (Nasdaq: RGDO), a biopharmaceutical company focused on the late-stage clinical development of its first-in-class, actively controllable antithrombotic drug system, REG1, today announced that the United States Food and Drug Administration (FDA) has accepted the company's investigational new drug (IND) application for REG2. Regado previously completed a single escalating-dose Phase 1 clinical trial of REG2 and plans to conduct additional clinical testing in sub-acute venous thrombosis indications in the future.

REG2 is comprised of a subcutaneous depot formulation of Regado's aptamer-based anticoagulant pegnivacogin designed for a slower onset of activity and a durable antithrombotic effect. Like REG1, it is paired with an intravenous (I.V.) bolus formulation of anivamersen intended to be used as an active control agent, if needed.

"Our Phase 3 REGULATE-PCI trial of REG1 remains our primary focus at Regado, however the FDA's acceptance of the IND for REG2 is a significant accomplishment that extends our clinical pipeline and advances our mission of transforming the anticoagulation therapeutic market," said David J. Mazzo, Ph.D., chief executive officer of Regado Biosciences. "We believe there is significant medical need for a safe, extended-release anticoagulant for sub-acute indications, and, based on the safety and clinical results for pegnivacogin to date with REG1, we are enthusiastic about advancing REG2 further into clinical development."