The United States Food and Drug Administration (FDA) has accepted Regado Biosciences, Inc's investigational new drug (IND) application for REG2. Regado previously completed a single escalating-dose phase I clinical trial of REG2 and plans to conduct additional clinical testing in sub-acute venous thrombosis indications in the future.
REG2 is comprised of a subcutaneous depot formulation of Regado's aptamer-based anticoagulant pegnivacogin designed for a slower onset of activity and a durable antithrombotic effect. Like REG1, it is paired with an intravenous (I.V.) bolus formulation of anivamersen intended to be used as an active control agent, if needed.
"Our phase III REGULATE-PCI trial of REG1 remains our primary focus at Regado, however the FDA's acceptance of the IND for REG2 is a significant accomplishment that extends our clinical pipeline and advances our mission of transforming the anticoagulation therapeutic market," said David J Mazzo, Ph.D., chief executive officer of Regado Biosciences. "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."
REG2 is an early clinical-stage programme evaluating an extended release formulation of pegnivacogin, the same Factor IXa inhibiting anticoagulant used in REG1. REG2 is formulated for subcutaneous depot injection and is intended to provide a controllable level of anticoagulation for up to two weeks for sub-acute uses, especially in cases where a patient may be unable to swallow an oral anticoagulant. Regado is developing REG2 for potential uses in a variety of acute and sub-acute care cardiovascular indications such as venous thromboembolism prophylaxis in patients undergoing abdominal surgery, as treatment for transcatheter aortic valve implantation (TAVI) patients and for bridging patients who are unable to take oral anticoagulants for a period of time before or after a surgical procedure.
Regado Biosciences, Inc., is a biopharmaceutical company focused on the development of novel, first-in-class, actively controllable antithrombotic drug systems for acute and sub-acute cardiovascular indications.