GlaxoSmithKline (GSK) has initiated the Phase III EAGLE clinical programme of its investigational antibiotic, gepotidacin, for the treatment of uncomplicated urinary tract infection (uUTI, acute cystitis) and urogenital gonorrhoea (GC).

Gepotidacin belongs to the triazaacenaphthylene bacterial topoisomerase inhibitors antibiotic class. The drug specifically acts on the DNA gyrase and topoisomerase IV enzymes involved in bacterial replication.

The Phase III programme of gepotidacin comprises EAGLE-1 and EAGLE-2 trials. Dosing of patients in the programme has already been commenced.

EAGLE-1 will evaluate oral gepotidacin compared to intramuscular ceftriaxone in combination with oral azithromycin over 21 days in around 600 participants with GC caused by Neisseria gonorrhoea (NG).

The trial’s primary endpoint is the culture-confirmed NG eradication from the urogenital body site during the test-of-cure (TOC) visit.

EAGLE-2 is designed to compare oral gepotidacin to the oral dose of a first-line antibiotic called nitrofurantoin over 28 days in around 1,200 uUTI patients.

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The trial will measure therapeutic response at the TOC visit as the primary endpoint in patients with qualifying uropathogens.

Initial results from the trials are expected to be reported by the end of 2021.

GSK chief scientific officer and R&D president Dr Hal Barron said: “Given the increasing rate of antibiotic drug resistance, and gepotidacin’s unique mechanism of action, we believe this drug has the potential to transform the treatment landscape for patients with uncomplicated urinary tract infection and urogenital gonorrhoea who currently have limited therapeutic options.”

The Phase III programme is supported by positive data from two Phase II trials, which tested gepotidacin in patients with GC and acute bacterial skin and skin structure infections (ABSSSI).

GSK noted that the antibiotic’s development is made possible through an alliance with the US Biomedical Advanced Research and Development Authority (BARDA) and Defense Threat Reduction Agency (DTRA).