Slide One

AB-DIRECT

Antibiotic, Distribution & Recovery

Objectives

Gepotidacin is a novel antibiotic currently under development. The objective of the project is to explore a potential new option for the treatment of pharyngeal Neisseria gonorrhoeae infections or prostatitis caused by Escherichia coli by demonstrating adequate penetration of a novel antibiotic in tonsillar and prostate tissues.

 This will be achieved in the project by:

  • Conducting in vivo studies to predict human exposures of gepotidacin in healthy and infected prostate;
  • Measuring gepotidacin levels in tonsillar and prostate tissue by ex vivo microdialysis following single oral dose of gepotidacin in subjects undergoing elective tonsillectomy or prostatectomy;
  • Refining the PBPK and the population pharmacokinetic (PopPK) models based on the generated clinical data to describe gepotidacin penetration into human tonsillar and prostate tissue;
  • Developing a pharmacokinetic-pharmacodynamic (PKPD) model that relates the gepotidacin tissue exposure (PK) with the effect (PD) from time-kill curves using E. coli and N. gonorrhoeae;
  • Determining the probability for target attainment for 90% of the subjects in plasma, prostate and tonsils based on data from microdialysis study healthy volunteers to support the evaluation of dosing regimens for each disease;
  • Analysing the prostate non-clinical and clinical data, evaluate and contribute to the current understanding of translation across species.