PhaseBio Pharmaceuticals, Inc. announced the completion of the bentracimab drug substance and drug product Process Performance Qualification (PPQ) campaign. Bentracimab, PhaseBio's lead drug candidate, is currently in late-stage clinical development in the REVERSE-IT (Rapid and SustainEd ReVERSal of TicagrElor – Intervention Trial) trial. REVERSE-IT 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. In November 2021, PhaseBio presented positive interim results from the REVERSE-IT trial during a Late-Breaking Science Session at the 2021 American Heart Association Scientific Sessions. In December 2021, the REVERSE-IT interim results were subsequently published in NEJM Evidence, a new digital journal from the NEJM (New England Journal of Medicine) Group.

The Company is targeting a BLA submission to FDA in mid-2022. 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.