PhaseBio Pharmaceuticals has reported positive data from the Phase IIb clinical trial of bentracimab which has been designed to treat patients with uncontrolled bleeding or requiring surgery.
A new, recombinant, human monoclonal antibody antigen-binding fragment, bentracimab is created to reverse ticagrelor’s antiplatelet activity.
The multicentre, double-blind, randomised, placebo-controlled trial enrolled 205 older subjects aged 50-80 years.
All these participants received dual anti-platelet therapy comprising ticagrelor and low-dose aspirin. Subsequently, 154 subjects were given bentracimab while 51 received placebo.
Reversing ticagrelor’s platelet function inhibition in bentracimab-treated participants versus placebo was the primary endpoint of the trial.
Findings showed that bentracimab treatment substantially restored platelet function within five minutes of dosing.
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Furthermore, it did not cause any drug-related serious adverse events or thrombotic events in the trial.
Bentracimab was demonstrated to be well tolerated, with only non-serious adverse events reported in the trial.
The safety and efficacy data from this trial are in line with those from the concluded Phase I and Phase IIa trials.
PhaseBio chief medical officer John Lee said: “The trial results provide support for the safety and efficacy profile of bentracimab and also provide key safety data that will be included as part of our planned Biologics License Application (BLA) submission to the FDA, which remains on track for mid-2022.”
The Phase IIb trial was carried out in parallel with the Phase III REVERSE-IT trial of bentracimab underway, as agreed following an End-of-Phase 1 meeting with the US Food and Drug Administration (FDA).
In December last year, the company voluntarily halted the Phase IIb trial of pemziviptadil (PB1046) for the treatment of pulmonary arterial hypertension in adults.