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Trial to Test Drug Combination for Hospital Infections

Acinetobacter baumannii bacteria

Scanning electron microscope image of Acinetobacter baumannii bacteria (CDC.gov)

26 October 2016. A clinical trial scheduled for early 2017 plans to assess the activity of two drugs to treat antibiotic-resistant infections often found in health care facilities. The early-stage trial is testing the combination of an experimental drug code-named ETX2514 by Entasis Therapeutics, working with sulbactam, a current antibiotic drug.

ETX2514 is designed by Entasis to treat infections from Acinetobacter baumannii, an opportunistic gram-negative bacteria often infecting people in hospitals, including combat troops in conflict zones, with compromised immune systems. Gram-negative bacteria are associated with conditions such as pneumonia, bloodstream infections, wound, and surgical site infections. “Gram” refers to a classification for bacteria where the microbes either retain (gram-positive) or shed (gram-negative) a test stain on their protective cell coatings.

Entasis Therapeutics is a spin-off company from drug maker AstraZeneca, founded last year in Waltham, Massachusetts and given the rights to AstraZeneca’s small molecule, or low molecular weight, anti-infection drug candidates, including ETX2514. As reported in Science & Enterprise, Entasis is also testing a new drug to treat gonorrhea in intermediate-stage trials.

ETX2514 is in a class of drugs known as beta-lactamase inhibitors that in their original formulations are becoming ineffective against new resistant bacterial strains. Entasis designed ETX2514 to work with sulbactam, a current beta-lactamase inhibitor. The company says in preclinical studies, ETX2514 was shown to restore the antibiotic potency of sulbactam. The drugs are given as injections.

The clinical trial plans to recruit 124 healthy volunteers in Australia, who will test the safety and chemical activity in the body of ETX2514 and sulbactam. Participants will be randomly assigned to receive the ETX2514 and sulbactam combination, ETX2514 alone, or a placebo in increasing dosage levels. The study team will look for any adverse effects and tolerability of the treatments. The researchers will also take periodic blood and urine samples to assess the chemical activity of the drugs as they are processed by the volunteers.

The study is being conducted in Australia by contract research companies INC Research and Nucleus Network. Recruitment of participants has not yet begun for the trial.

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