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.