FDA Accepts Regado Biosciences' Application For REG2
By Cyndi Root
Regado Biosciences, Inc. announced in a press release that the Food and Drug Administration (FDA) has approved its investigational new drug (IND) application for REG2 for venous thrombosis. David J. Mazzo, Ph.D., Chief Executive Officer of Regado Biosciences said, "We believe there is significant medical need for a safe, extended-release anticoagulant for sub-acute indications, and based on the safety and clinical results for pegnivacogin to date with REG1, we are enthusiastic about advancing REG2 further into clinical development."
Venous thrombosis is a common condition for people over the age of 60, but it can occur to anyone at any age. It occurs when a blood clot forms in the veins, usually the legs. If the clot detaches and travels through the bloodstream, an embolism can result in the brain, heart, lungs, or other part of the body. Certain risks factors make the condition more likely such as a family history of blood clots, obesity, and giving birth.
REG2 is made from the anticoagulant pegnivacogin for its slow release and anti-thrombotic effect and combined with anivamersen, an active control agent. The agent is injected subcutaneously. This formulation helps people who may not be able to take it orally and provides a two week controlled release. REG2 is being investigated for a variety of uses other than venous thrombosis. It has possibilities as a prophylactic agent prior to abdominal surgery to prevent venous thromboembolism. It could treat patients with transcatheter aortic valve implantation (TAVI). It may also be used for a variety of surgeries where the patient is unable to take an oral anticoagulant.
REG2 is part of Regado’s drug discovery program for antithrombotic agents that assist in treatment of cardiovascular disease. REG1 is an anti-coagulation system with two components, a Factor IXa inhibitor anticoagulant and a control agent. It is indicated for acute coronary syndrome (ACS) and coronary revascularization procedures. REG1 seeks to decrease bleeding incidence. REG3 is an anti-platelet agent consisting of a GPVI inhibitor and control agent. GPVI is a collagen receptor of interest as it is implicated in diabetes and rheumatoid arthritis.
Regado Biosciences, Inc. is a biopharmaceutical company focused on antithrombotic drug systems for cardiovascular conditions. Its two-part system of active agent and control agent represents a novel approach. The FDA’s approval clears the way for additional REG2 trials.