Entasis Therapeutics has commenced a Phase I clinical trial evaluating ETX0282 in combination with ETX0282CPDP to treat infections caused by multidrug-resistant (MDR) Gram-negative pathogens, including MDR and carbapenem-resistant Enterobacteriaceae (CRE).
The randomised, double-blind, placebo-controlled trial aims to investigate the safety, tolerability and pharmacokinetics of ETX0282 alone and in combination with cefpodoxime.
Currently being conducted in Australia on healthy subjects, the trial is scheduled to be completed in the first half of next year.
Entasis Therapeutics president and CEO Manos Perros said: “The initiation of clinical studies for ETX0282, what we believe is the first broad-spectrum oral beta-lactamase inhibitor to enter the clinic, marks an important milestone for Entasis and a meaningful step toward the development of an effective oral therapy for patients suffering from drug-resistant bacterial infections.
“By providing the option of an effective course of oral antibiotic treatment, EXT0282CPDP has the potential to benefit patients as well as the healthcare systems by reducing the risk of nosocomial infections and avoiding the healthcare costs associated with hospitalisations.”
ETX0282 is a new oral beta-lactamase inhibitor while ETX0282CPDP is a combination of ETX0282 and cefpodoxime, an orally available cephalosporin approved for treatment of various bacterial infections.
Entasis Therapeutics chief medical officer Robin Isaacs said: “We believe that ETX0282CPDP has the potential to provide an effective oral therapy option for patients with complicated urinary tract infections due to MDR Enterobacteriaceae.”
Development of ETX0282CPDP has been partially supported by a grant provided by Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator program (CARB-X), a public-private partnership focused on early stage antibacterial research and development.