PhaseBio Announces Completion of Dosing in First Cohort of Phase 1 Clinical Trial of PB2452
PhaseBio Pharmaceuticals announced that it has completed dosing in the first cohort of subjects in its Phase 1 clinical trial of PB2452 (formerly MEDI2452), a reversal agent for the antiplatelet therapy ticagrelor.
The randomized, double-blind, placebo-controlled, single ascending dose trial is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous PB2452 with and without ticagrelor pre-treatment in up to nine cohorts and a total of approximately 60 healthy volunteers.
“PB2452 has the potential to rapidly and specifically reverse the antiplatelet effects of ticagrelor in rare emergency situations, like urgent surgery or severe bleeding, providing a unique differentiator among oral P2Y12 antagonist antiplatelet agents,” said John Lee, M.D., Ph.D., Chief Medical Officer of PhaseBio. “In preclinical studies, PB2452 demonstrated high affinity and specific binding to ticagrelor, and was shown to reverse ticagrelor-mediated inhibition of platelet aggregation and to normalize bleeding. PhaseBio in-licensed PB2452 from MedImmune in November 2017, and we are thrilled with its rapid progression into clinical trials.”