May 10, 2018
PhaseBio Announces Completion of Dosing in First Cohort of Phase 1 Clinical Trial for Reversal Agent Ticagrelor
[Originally posted by PhaseBio— April 5, 2018]
PhaseBio Announces Completion of Dosing in First Cohort of Phase 1 Clinical Trial of PB2452, a Reversal Agent for Ticagrelor
PhaseBio Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing therapies for the treatment of orphan diseases, today 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.i PhaseBio in-licensed PB2452 from MedImmune in November 2017, and we are thrilled with its rapid progression into clinical trials.”
PB2452 (formerly MEDI2452) is a neutralizing Fab antibody fragment that binds to ticagrelor and its active metabolite AR-C124910XX, and is intended to reverse the antiplatelet effects of ticagrelor. The availability of PB2452 would enable reversal of the antiplatelet effects of ticagrelor in rare emergency situations and greatly reduce the waiting period before surgery.
PhaseBio Pharmaceuticals, Inc., is a clinical-stage biopharmaceutical company developing therapies for the treatment of orphan diseases. PhaseBio is leveraging its proprietary elastin-like polypeptide (ELP) biopolymer technology platform to develop therapies with the potential for less-frequent dosing and better patient compliance. PhaseBio’s lead development candidate, PB1046, is a first-in-class weekly vasoactive intestinal peptide (VIP) receptor agonist for the treatment of pulmonary arterial hypertension. The company is also developing PB2452, a reversal agent for the antiplatelet therapy ticagrelor. PhaseBio is privately owned, with headquarters and research laboratories in Malvern, PA. For more information, please visit www.phasebio.com.