Regado Biosciences Reports FDA Acceptance Of IND For REG2 - Quick Facts

(RTTNews) - Regado Biosciences, Inc. (RGDO), a biopharmaceutical company focused on the late-stage clinical development of its first-in-class, actively controllable antithrombotic drug system, REG1, reported that the United States Food and Drug Administration or FDA has accepted the company's investigational new drug or IND application for REG2. Earlier, Regado completed a single escalating-dose Phase 1 trial of REG2 and intends 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 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 Mazzo, chief executive of Regado Biosciences.