PhaseBio Announces First Patient Dosed in Phase 2b Clinical Trial of PB2452 for Reversal of the Antiplatelet Activity of Ticagrelor
The Phase 2b multi-center, randomized, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of PB2452 in reversing the antiplatelet effects of ticagrelor as part of a dual antiplatelet regimen including low-dose aspirin. Additionally, the Phase 2b trial marks the beginning of
“We are pleased that the first patient has been dosed in the registrational Phase 2b clinical trial of PB2452, as it signifies continued progress on our Accelerated Approval pathway discussed with the
PhaseBio recently completed a Phase 2a trial in which PB2452 achieved immediate and sustained reversal of the antiplatelet effects of ticagrelor in older and elderly subjects on dual antiplatelet therapy of ticagrelor and low-dose aspirin. PB2452 was generally well tolerated, with only minor adverse events reported. These results are consistent with the results observed in healthy younger subjects treated with ticagrelor in the previously published Phase 1 trial. Additionally, the Phase 2a trial investigated a PB2452 regimen for the reversal of supratherapeutic doses of ticagrelor in healthy younger subjects, which demonstrated immediate and sustained reversal of the antiplatelet effects of ticagrelor and was well tolerated, consistent with the earlier cohorts in the Phase 2a trial and the Phase 1 trial.
PB2452 is a novel, recombinant, human monoclonal antibody antigen-binding fragment designed to reverse the antiplatelet activity of ticagrelor in major bleeding and urgent surgery situations. In a Phase 1 clinical trial, PB2452 demonstrated the potential to bring life-saving therapeutic benefit through immediate and sustained reversal of ticagrelor’s antiplatelet activity, mitigating concerns regarding bleeding risks associated with the use of antiplatelet drugs. The Phase 1 clinical trial of PB2452 in healthy volunteers was published in the
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Forward-looking statements include statements concerning or implying the conduct or timing of our clinical trials, timelines for regulatory submissions and our research, development and regulatory plans for PB2452, PB1046 and our ELP research programs. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.
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Chief Financial Officer
1. Bhatt DL, Pollack CV, Weitz JI, et al. Antibody-Based Ticagrelor Reversal Agent in
Source: PhaseBio Pharmaceuticals, Inc.