Regado Biosciences Shows Safety Of Early Sheath Removal In Phase 2b Trial

(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 the publication of additional findings from its completed Phase 2b RADAR study in the Journal of Invasive Cardiology showing the safety of early sheath removal in patients treated with REG1.

The analysis showed that REG1 allowed for very early arterial sheath removal following cardiac catheterization without increasing the time to hemostasis or the frequency of vascular access-site bleeding complications. Moreover, the trial determined that patients anticoagulated with REG1 during cardiac catheterization had their arterial sheath removed an average of over 3 hours earlier than those anticoagulated with unfractionated heparin.

Regado is currently testing REG1 in a Phase 3 trial, REGULATE-PCI, designed to show superiority in efficacy and non-inferiority in safety against the current standard, bivalirudin. The first of three key interim analyses in the study would occur after enrollment of the first 1,000 patients, which may happen in the second quarter of 2014.