Pharmacodynamics Evaluation of PhaseBio’s Novel Ticagrelor Reversal Agent Presented at ESC Congress 2019
“Utilizing multiple assays of platelet function provided a wider range of understanding of the pharmacodynamics of PB2452 in the first-in-human clinical trial,” said Dr. Jennings. “PB2452 provided immediate and sustained reversal of ticagrelor antiplatelet activity, which could reduce the bleeding risk associated with ticagrelor. The Phase 1 data support further evaluation of PB2452 for the reversal of the antiplatelet effects of ticagrelor in emergency situations involving major bleeding and to enable emergent or urgent surgery in patients.”
The first-in-human, randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluated the safety, efficacy and pharmacokinetics of intravenous PB2452 as a ticagrelor reversal agent in 64 healthy volunteers aged 18 to 50 years. Platelet function was assessed using light transmission aggregometry, VerifyNow PRUTest and vasodilator stimulated phosphoprotein (VASP) assays. VerifyNow PRUTest is considered to be the gold standard for point-of-care assessments of platelet function. The data demonstrated that complete reversal by all measurements occurred within 15 minutes of administration and was sustained for over 20 hours.
PhaseBio has continued to use the same three assays to demonstrate the efficacy of PB2452 in a Phase 2a trial and has continued to see a high degree of correlation among the assays in both trials.
“These primary measures of efficacy in our clinical trials are a key feature of the Accelerated Approval program that will help streamline the defined regulatory path for PB2452, coupled with its Breakthrough Therapy designation,” said
Additional information including the abstract can be found on the ESC Congress website here.
PB2452 is a novel, recombinant, human monoclonal antibody antigen-binding fragment, or Fab, 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
PhaseBio is located in Malvern, PA and San Diego, CA. For more information, please visit www.phasebio.com.
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Source: PhaseBio Pharmaceuticals, Inc.