Regado Biosciences Initiates Clinical Study Of REG1 Anticoagulation System
Regado Biosciences enrolled the first patient in a multi-center, open-label, randomized Phase IIa clinical study, named REVERSAL-PCI, of its REG1 Anticoagulation System.
The patient was enrolled at Black Hills Cardiology in Rapid City, SD. The study will enroll 26 patients undergoing elective Percutaneous Coronary Intervention (PCI) to assess whether REG1 can replace standard heparin therapy during the performance of coronary balloon angioplasty dilatation and stenting on patients at low-risk for complications associated with therapy-related bleeding or heart attack. The REG1 Anticoagulation System is a combination of RB006, an intravenous anticoagulant, and its highly specific, rapidly acting antidote, RB007.
All patients will be pretreated with clopidogrel and aspirin to inhibit platelet activity. Primary procedural success will be defined by absence of significant bleeding events up to hospital discharge or 48 hours post stenting, and by absence of death, nonfatal heart attack, or need to repeat revascularization up to day 14. The study will be conducted at sites in the United States and Argentina.
"There is a significant and immediate need for an anticoagulant therapy that can be adjusted quickly and easily based on the changing medical condition of the patient. Our Phase I studies in healthy volunteers and in patients with stable coronary artery disease showed REG1 provided a safe, potent, and quickly reversible anticoagulant effect," stated Douglas Gooding, Chief Executive Officer of Regado Biosciences. "Our plan is to build on our existing data set and initiate several additional Phase II studies to establish proof of concept in a wide range of coronary revascularization procedures."
Regado has conducted three Phase I clinical studies of REG1, all of which demonstrated the anticoagulation system is safe and the antidote effective in both healthy volunteers and in older patients with stable coronary artery disease.
"I am very pleased with the results of this first clinical experience with the REG1 system during a stent procedure. We anticipate this drug will fulfill multiple unmet needs in the care of heart patients," stated Mauricio Cohen, MD, the Director of Cardiology Clinical Trials at the University of North Carolina and Principal Investigator of the REVERSAL-PCI study. "The lack of a safe and at the same time efficacious reversible blood thinner has been a major problem for cardiologists performing invasive catheterization procedures. We are hopeful that this agent will revolutionize the approach to anticoagulation during catheter-based interventions and the care of heart attack patients."
Currently, heparin and protamine are the only approved therapeutic/antidote drug pair used in surgical procedures, such as PCI. However, these drugs have well-known limitations, including the risk for developing heparin-induced thrombocytopenia (with or without thrombosis), as well as protamine-associated side effects, such as anaphylaxis and systemic hypotension.
Regado's lead product candidate, REG1, is the first specific, direct-acting, antidote-controlled anticoagulant ever described. Regado is developing REG1 for use in patients suffering from acute coronary syndrome who undergo coronary revascularization procedures. These procedures, which include coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI), put patients at a high-risk for therapy-related bleeding complications. REG1 is being developed initially to increase therapeutic flexibility and improve patient outcomes in coronary revascularization procedures.
REG1 is a two-component system, consisting of an aptamer-based anticoagulant and its matched antidote. The REG1 anticoagulant component (RB006) is a single-stranded, nucleic acid aptamer. RB006 selectively and potently binds to and inhibits Factor IXa, a protein that is critical to blood coagulation. The antidote component, RB007, is a complementary nucleic acid that binds to and neutralizes RB006. The binding of RB007 to RB006 causes the predictable and rapid reversal of RB006 that allows the patient's blood to return to normal.