Regado Biosciences announces FDA’s clinical hold of Ph III trial

The US Food and Drug Administration (FDA) has informed US-based cardiovascular specialist Regado Biosciences (Nasdaq: RGDO) that a clinical hold has been placed on all patient enrolling and dosing of either study drug in the ongoing Phase III REGULATE-PCI trial.

The FDA says this action was taken in order to formalize their involvement in any decision to re-initiate enrolment and dosing in the trial in the future, as Regado has already voluntarily paused enrolment in the trials.

The REGULATE-PCI trial is a worldwide Phase III study that compares the safety and efficacy of Regado’s Revolixys Kit against bivalirudin in 13,200 patients with acute coronary syndromes undergoing percutaneous coronary intervention, which is a hospital-based procedure used to mechanically open or widen obstructed coronary arteries. It is a two-component system consisting of pegnivacogin (an anticoagulant aptamer), and its complementary oligonucleotide active control agent, anivamersen.