Regado Biosciences announces enrollment of first patient in REGULATE-PCI clinical trial

Regado Biosciences, Inc. (Nasdaq: RGDO), a biopharmaceutical company focused on the discovery and development of novel, first-in-class, actively controllable antithrombotic drug systems for acute and sub-acute cardiovascular indications, today announced the enrollment of the first patient in its REGULATE-PCI clinical trial. REGULATE-PCI is a Phase 3, PROBE design (Prospective, Randomized, Open-label, Blinded-Endpoint) superiority study comparing the effects of Regado's REG1 to bivalirudin in patients undergoing percutaneous coronary intervention (PCI) electively or for the treatment of unstable angina (UA) or non-ST elevated myocardial infarction (N-STEMI). REGULATE-PCI, if successful, will serve as the basis for product registration applications throughout the world.

Led by co-principal investigators, Drs. John H. Alexander of Duke University Medical Center, A. Michael Lincoff of The Cleveland Clinic and Roxana Mehran of Mount Sinai School of Medicine, REGULATE-PCI is expected to enroll 13,200 patients at approximately 500 investigational sites worldwide. The primary endpoint of the trial is efficacy compared to bivalrudin based on a composite of death, nonfatal myocardial infarction (MI), nonfatal stroke and urgent target lesion revascularization through day three. The principal secondary endpoint is safety compared to bivalrudin as measured by major bleeding events through day three. The trial is powered to show superiority in efficacy and non-inferiority in safety against bivalirudin. If successful, REGULATE-PCI will become the cornerstone of Regado's international new drug applications, expected to be filed in early 2016. The first of three key interim analyses in the trial will occur after enrollment of the first 1,000 patients and is expected to occur during the second quarter of 2014.

David J. Mazzo, Ph.D., President and CEO of Regado Biosciences, explained, "The initiation of our Phase 3 clinical trial is a momentous occasion for Regado, our investors and the cardiovascular community as a whole. Not only does REGULATE-PCI herald a new age in acute care cardiovascular trial design, but it is unique among other recent PCI trials in its aim to demonstrate superiority of a new therapy. If REG1 achieves the successful results we expect, this trial could pave the way for REG1 to become the new standard of care for anticoagulant use in PCI treatments by providing better outcomes for patients, optimized control for physicians and pharmacoeconomic benefits for payers." 

Steven L. Zelenkofske, D.O., F.A.C.C., Senior Vice President, Clinical and Medical Affairs and Chief Medical Officer, remarked, "I am very proud of the entire team at Regado who, working with our world renowned medical advisors, as well as the numerous investigators and trial sites, have prepared and launched a trial of this magnitude and scope with the aim of demonstrating that REG1 can provide the first major improvement in efficacy in over a decade among anticoagulants used in PCI."   

Dr. Mazzo concluded, "We believe that there is an immediate need for a PCI anticoagulant therapy that reduces ischemic complications and major bleeding rates while contributing to overall reductions in procedure time and cost of care.  We believe that REG1 will demonstrate that it can satisfy this need and, in so doing, become the anticoagulant of choice in patients undergoing PCI."