Quantification of unbound concentration of ticagrelor in plasma as a proof of mechanism biomarker of the reversal agent, MEDI2452

PLoS One. 2018 Jul 26;13(7):e0201202. doi: 10.1371/journal.pone.0201202. eCollection 2018.

Abstract

Ticagrelor, a P2Y12 antagonist, is approved for prevention of thromboembolic events. MEDI2452 is a potential reversal agent for ticagrelor and ticagrelor active metabolite (TAM). The total plasma exposure of ticagrelor and TAM in patients are roughly 0.5-1 and 0.2-0.5 μmol/L, respectively. Both have similar high potency vs. P2Y12 (Ki 2 nmol/L) but are plasma protein-bound to 99.8% and only the 0.2% free fraction is able to inhibit the P2Y12 receptor. Thus, for unbound concentration measurements to be a proof of mechanism biomarker for MEDI2452 a very high sensitivity is required. Using established techniques as equilibrium dialysis and LC-MS/MS, made it possible to evaluate the efficacy of the reversal agent by measuring reduction of unbound concentration of ticagrelor in the presence of MEDI2452. With challenges such as ultra-low concentrations, small sample volumes, recovery issues and adsorption to plastic we managed to develop a highly sensitive assay for determining unbound concentration levels of ticagrelor and TAM in plasma with a quantification limit of 30 pmol/L and 45 pmol/L, respectively. With this method we were able to detect close to a 100-fold MEDI2452 mediated reduction in the unbound concentration of both ticagrelor and TAM. The assay provided proof of mechanism as MEDI2452 concentration- and dose-dependently eliminated unbound concentration of ticagrelor and reversed its antiplatelet activity in preclinical models and will support future development of MEDI2452.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Antibodies, Neutralizing / blood*
  • Antibodies, Neutralizing / pharmacology
  • Antidotes* / pharmacology
  • Blood Chemical Analysis*
  • Blood Specimen Collection
  • Broadly Neutralizing Antibodies
  • Chromatography, Liquid
  • Dialysis
  • Dose-Response Relationship, Drug
  • Humans
  • Mass Spectrometry
  • Mice
  • Platelet Aggregation / drug effects
  • Platelet Aggregation Inhibitors / blood*
  • Platelet Aggregation Inhibitors / pharmacology
  • Purinergic P2Y Receptor Antagonists / blood*
  • Purinergic P2Y Receptor Antagonists / pharmacology
  • Sus scrofa
  • Ticagrelor / blood*
  • Ticagrelor / pharmacology

Substances

  • Antibodies, Neutralizing
  • Antidotes
  • Broadly Neutralizing Antibodies
  • Platelet Aggregation Inhibitors
  • Purinergic P2Y Receptor Antagonists
  • PB-2452
  • Ticagrelor

Grants and funding

The authors confirm that the funder AstraZeneca, provided support in the form of salaries for authors [AS, AJ, SP, SN], but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the author contributions section.