Bentracimab (previously PB2452) 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 antiplatelet drugs. Additionally, in a translational study, bentracimab achieved equivalent reversal of branded ticagrelor and multiple ticagrelor generics.
Bentracimab 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. PhaseBio expects to complete enrollment of the first 100 patients in the REVERSE-IT trial in mid-2021, and is targeting to submit its BLA for bentracimab in mid-2022, although those timelines could be impacted by the continued scope and duration of the COVID-19 pandemic. To date, nearly all of the patients enrolled have required urgent surgery or an invasive procedure.
We are also currently conducting a Phase 2B trial in older (ages 50-80) patients to evaluate the efficacy of bentracimab in reversal of ticagrelor. Enrollment is ongoing in the US and Canada with a 3:1 randomization (active: placebo). The primary endpoint is reversal measured by VerifyNow. The secondary endpoints are safety, PK and immunogenicity.
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