Regado Biosciences Inc. announced the permanent termination of enrollment in its REGULATE-PCI Phase 3 trial for its lead program, Revolixys Kit. The decision was made based on a recommendation from the trial’s Data and Safety Monitoring Board (DSMB) following their analysis of the data from the first approximately 3250 patients enrolled in what was intended to be a 13,200-patient trial comparing the safety and efficacy of Revolixys Kit with bivalirudin.
“The DSMB indicated that the level of serious allergic adverse events associated with Revolixys was of a frequency and severity such that they recommended that we do not enroll any further patients in the REGULATE-PCI trial,” stated David Mazzo, CEO of Regado. He continued: “We will now undertake a complete review of the unblinded database from REGULATE-PCI, which we expect will take several months to complete.”
Date: August 25, 2014
Source: Regado Biosciences
Filed Under: Drug Discovery