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REGULATE-PCI trial placed on clinical hold

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The FDA has placed a clinical hold on enrollment and dosing for the ongoing phase 3 REGULATE-PCI trial, according to a press release from Regado Biosciences.

The open-label, randomized, multicenter study was designed to evaluate the safety and efficacy of the Revolixys Kit (formerly REG1), a first-in-class antithrombotic drug system, compared with bivalirudin (The Medicines Company) for the prevention of periprocedural ischemic events and major bleeding in patients undergoing PCI for treatment of CAD. The two-component Revolixys system consists of pegnivacognin, an anticoagulant aptamer that specifically targets coagulation Factor IXa, and anivamersen, its complementary oligonucleotide active control agent, according to the release.

The clinical hold follows a voluntary pause in trial enrollment announced earlier in July, after the Data Safety Monitoring Board (DSMB) initiated an unplanned review of trial data. The DSMB is conducting an analysis of benefit-risk ratio and safety among 3,234 currently enrolled patients, particularly with regard to allergy-related serious adverse events. The DSMB analysis report and recommendations are anticipated within the next 8 weeks, according to the release.

“We remain blinded to REGULATE-PCI study data and are awaiting the outcome of the full safety and efficacy analysis, including an analysis of benefit/risk ratio, being performed by our Data and Safety Monitoring Board,” David J. Mazzo, CEO of Regado Biosciences, stated in the release. “Any recommendation to re-initiate patient enrollment in REGULATE-PCI will be based on the DSMB's conclusions and would always be implemented in agreement with FDA."