US-based biopharmaceutical firm Regado Biosciences (RGDO) has enroled the first patient in a Phase III clinical trial of REG1, a two-component system consisting of pegnivacogin, an anticoagulant aptamer specifically targeting coagulation Factor IXa, and its complementary oligonucleotide active control agent, anivamersen.
REGULATE-PCI is a PROBE (prospective, randomized, open-label, blinded-endpoint) study designed to determine the efficacy of REG1 compared to bivalirudin in patients undergoing percutaneous coronary intervention (PCI) or for the treatment of unstable angina (UA) or non-ST elevated myocardial infarction (N-STEMI).
Under the trial, the company expects to enrol a total of 13,200 patients at about 500 sites around the world and if successful, the study will become the basis of its international new drug applications, expected to be filed in early 2016.
While 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 secondary endpoint compares safety as measured by major bleeding events through day three.
The company hopes to conduct the first interim analysis after it completes the enrolment of 1,000 patients during the second quarter of 2014.
Regado Biosciences president and CEO David Mazzo said: "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."
Regado is developing REG1 as an effective PCI anticoagulant therapy that reduces ischemic complications and major bleeding rates while contributing to overall reductions in procedure time and cost of care.
It will be used in patients with a wide range of acute coronary syndromes, undergoing PCI, a hospital-based procedure used to mechanically open or widen obstructed coronary arteries.