Pharmacokinetics of the phage endolysin-based candidate drug SAL200 in monkeys and its appropriate intravenous dosing period

Clin Exp Pharmacol Physiol. 2016 Oct;43(10):1013-6. doi: 10.1111/1440-1681.12613.

Abstract

SAL200 is a new phage endolysin-based candidate drug for the treatment of staphylococcal infections. An intravenous administration study was conducted in monkeys to obtain pharmacokinetic information on SAL200 and to assess the safety of a short SAL200 dosing period (<1 week). Maximum serum drug concentrations and systemic SAL200 exposure were proportional to the dose and comparable in male and female monkeys. SAL200 was well tolerated, and no adverse events or laboratory abnormalities were detected after injection of a single dose of up to 80 mg/kg per day, or injection of multiple doses of up to 40 mg/kg per day.

Keywords: antibiotic resistant; intravenous administration; monkey; phage endolysin; staphylococci.

Publication types

  • Letter
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Anti-Bacterial Agents / administration & dosage*
  • Anti-Bacterial Agents / pharmacokinetics*
  • Bacteriophages
  • Dose-Response Relationship, Drug
  • Endopeptidases / administration & dosage*
  • Endopeptidases / pharmacokinetics*
  • Female
  • Haplorhini
  • Infusions, Intravenous
  • Male
  • Methicillin-Resistant Staphylococcus aureus / drug effects*
  • Methicillin-Resistant Staphylococcus aureus / physiology
  • Phage Therapy / methods*
  • Staphylococcal Infections / drug therapy
  • Staphylococcal Infections / metabolism

Substances

  • Anti-Bacterial Agents
  • Endopeptidases
  • endolysin