PhaseBio Pharmaceuticals is planning to announce PB2452, a novel reversal agent for the Antiplatelet drug Ticagrelor.
PB2452 is a novel, recombinant, human monoclonal antibody antigen-binding fragment, or Fab fragment, designed to reverse the Antiplatelet activity of ticagrelor in major bleeding and urgent surgery situations.
PB2452 achieved immediate and sustained reversal of ticagrelor’s Antiplatelet effects in Phase I trial results.
It highlights the critical unmet need for a therapy to reverse the antiplatelet activity of Ticagrelor, which is widely prescribed to patients with acute coronary syndrome or a history of heart attack.
The results from the Phase I clinical trial of PB2452 exhibited immediate and sustained reversal of the antiplatelet activity of ticagrelor, which could mitigate bleeding concerns associated with use of ticagrelor.
The dose-escalation trial was designed to evaluate the safety and tolerability and determine proof of concept for PB2452 as a ticagrelor reversal agent in healthy subjects pre-dosed with ticagrelor.
PB2452 achieved rapid, complete and sustained reversal of ticagrelor’s antiplatelet activity with potential customizable duration of reversal based on the dosing regimen, in the trial.
In addition, there were no PB2452-related adverse events or serious adverse events reported.
The availability of a reversal agent such as PB2452 could uniquely position ticagrelor as the only oral Antiplatelet drug with a reversal agent and expand its use by mitigating concerns regarding the bleeding risk associated with Antiplatelet drugs.