PhaseBio announces data from evaluation of pharmacodynamics of PB2452
PhaseBio Pharmaceuticals announced that data from an evaluation of the pharmacodynamics of PB2452, a novel reversal agent for the antiplatelet drug ticagrelor, were presented by Lisa K. Jennings, Ph.D., Professor of Medicine, University of Tennessee Health Science Center, at ESC Congress 2019 in Paris on September 1. 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 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.