July 30, 2014 — Regado Biosciences announced earlier this month it has voluntarily paused enrollment in its REGULATE-PCI trial, which was testing the safety and effectiveness of its Revolixys pharmaceutical kit. The two-component system consists of pegnivacogin, an anticoagulant aptamer specifically targeting coagulation Factor IXa and its complementary oligonucleotide active control agent, anivamersen.
The company said the U.S. Food and Drug Administration (FDA) informed the company that a clinical hold has also been placed on all patient enrollment and dosing of either study drug in the ongoing phase III REGULATE-PCI trial. According to the FDA, this action was taken to formalize the involvement of the FDA in any decision to re-initiate enrollment and dosing in the trial in the future.
The REGULATE-PCI trial is a worldwide phase III trial comparing safety and efficacy of the Revolixys kit versus bivalirudin in 13,200 patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI). The study is designed to determine the efficacy of REG1 compared to bivalirudin in preventing periprocedural ischemic complications and major bleeding in patients undergoing PCI as a treatment for CAD (coronary artery disease). Bivalirudin has been studied in patients undergoing PCI in both ACS (non-ST segment elevated myocardial infarction [NSTEMI] and unstable angina [UA]) and elective PCI. In comparison to UFH, bivalirudin has shown similar rates of ischemic events while demonstrating a significant reduction in bleeding and an improved net clinical benefit.
Evidence from previous studies indicates that pegnivacogin represents an extremely potent, chemically unique anticoagulant that can be reversed by anivamersen across multiple populations. The question that still remains is whether Factor IX (FIX) inhibition by pegnivacogin can result in fewer ischemic events than a previously studied agent while active control with anivamersen can preserve the benefit of reduced bleeding. The purpose of this study is to evaluate REG1 in an adequately powered definitive study with an open-label, multicenter, active-controlled, randomized design to answer that question.
"As announced earlier, we remain blinded to REGULATE-PCI study data and are awaiting the outcome of the full safety and efficacy analysis, including an analysis of benefit/risk ratio, being performed by our data and safety monitoring board (DSMB). Any recommendation to re-initiate patient enrollment in REGULATE-PCI will be based on the DSMB's conclusions and would always be implemented in agreement with FDA," stated Regado CEO David Mazzo.
For more information: www.regadobio.com, www.clinicaltrials.gov/ct2/show/NCT01848106