PhaseBio Pharmaceuticals, Inc. announced that in conjunction with its financing and co-development partner for the European Union and China, SFJ Pharmaceuticals, PhaseBio has expanded its pivotal Phase 3 REVERSE-IT trial for its lead product candidate bentracimab into the European Union, having opened trial sites for enrollment and begun dosing its first patients. Bentracimab is a novel, human monoclonal antibody fragment that in earlier clinical trials has shown immediate and sustained reversal of the antiplatelet effects of Brilinta® (ticagrelor). Bentracimab has been studied in Phase 1 and Phase 2 clinical trials and has demonstrated the potential to bring life-saving therapeutic benefit through immediate and sustained reversal of the antiplatelet activity of ticagrelor, potentially mitigating concerns regarding bleeding risks associated with the use of this antiplatelet drug. Additionally, in a translational study, bentracimab achieved equivalent reversal of branded ticagrelor and multiple ticagrelor generics. Estimates from IQVIA® for 2019 suggest nearly 450,000 patients on Brilinta® (ticagrelor) in the United States, and approximately 1.2 million patients on Brilinta®/Brilique® (ticagrelor) in the 27 countries comprising the European Union, plus the United Kingdom, Switzerland, and Norway. REVERSE-IT (Rapid and SustainEd ReVERSal of TicagrElor – Intervention Trial) is a Phase 3, multi-center, open-label, prospective single-arm trial designed to study reversal of the antiplatelet effects of ticagrelor with bentracimab in patients who present with uncontrolled major or life-threatening bleeding or who require urgent surgery or invasive procedure. Approximately 200 patients are being targeted to be enrolled from major health centers worldwide. Patients with reported use of ticagrelor within the prior 3 days who require urgent ticagrelor reversal will be eligible for enrollment.