Bentracimab (previously PB2452) has been studied in Phase 1, Phase 2 and Phase 3 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. In August 2021, the enrollment for the interim analysis of REVERSE-IT Phase 3 trial was completed, and top-line data were reported in November 2021. Interim results from the REVERSE-IT trial showed:
- Bentracimab achieved primary reversal endpoint with immediate and sustained reversal of the antiplatelet effects of ticagrelor in both surgical and bleeding populations;
- Co-primary endpoint of clinical hemostasis achieved in greater than 90% of patients;
- Bentracimab appeared well tolerated with no drug-related serious adverse events.
Data from the Phase 2B and Phase 3 trials are expected to form the basis of a BLA submission for accelerated approval, which are currently being prepared and targeted for mid-2022.
PhaseBio also completed the Phase 2B study enrollment as of August 2021. The Phase 2B trial was designed to supplement the safety and efficacy results included in the planned BLA. The top-line results were reported in November 2021.
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