US-based clinical-stage biotechnology company PhaseBio Pharmaceuticals has dosed the first patient in a Phase IIb clinical trial of PB2452.
PB2452 is a novel, recombinant, human monoclonal antibody antigen-binding fragment designed to reverse the antiplatelet activity of ticagrelor in major bleeding activities and other surgery situations.
The multi-centred, randomised, double-blind, placebo-controlled Phase IIb trial will evaluate the safety and efficacy of PB2452 in reversing the antiplatelet effects of ticagrelor.
Patients will be on a dual antiplatelet therapy of ticagrelor and low-dose aspirin.
The trial also marks the beginning of US Food and Drug Administration (FDA) aligned registrational trials to submit the Biologics License Application (BLA) for PB2452 accelerated approval.
The study is expected to involve the participation of approximately 200 subjects aged 50 to 80, resembling the patient population most likely to be treated with ticagrelor and to potentially benefit from PB2452.
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Enrolled participants will be randomised in a ratio of 3:1 and will receive either PB2452 or placebo accordingly, with over 150 subjects receiving PB2452.
The primary endpoint of the trial will be achieved upon the reversal of the antiplatelet effects of ticagrelor with intravenous infusion of PB2452 or placebo. The reversal will be measured by the VerifyNow PRUTes biomarker.
PhaseBio Pharmaceuticals chief medical officer John Lee said: “We are pleased that the first patient has been dosed in the registrational Phase IIb clinical trial of PB2452, as it signifies continued progress on our accelerated approval pathway discussed with the FDA at our end-of-phase-one meeting.
“We continue to be encouraged by the potential of PB2452 to address a significant unmet need for patients by reversing the antiplatelet activity of ticagrelor in major bleeding and urgent surgery situations.
“Our plans to initiate our Phase III trial in the first quarter of 2020 and potentially submit a BLA for PB2452 in the second half of 2022 remain on track.”
The company recently completed a Phase IIa trial, with PB2452 achieving immediate and sustained reversal of the antiplatelet effects of ticagrelor in subjects who were put on dual antiplatelet therapy of ticagrelor and low-dose aspirin.