GSK declares positive data from Phase III gonorrhoea antibiotic trial

GSK has reported favorable outcomes from the Phase III EAGLE-1 clinical trial of gepotidacin, an oral bactericidal triazaacenaphthylene antibiotic, in treating uncomplicated urogenital gonorrhea (GC) in adolescent and adult patients. 

The non-inferiority trial involved nearly 600 subjects and compared the efficacy and safety of two 3,000mg doses of gepotidacin with the current combination treatment regimen of intramuscular ceftriaxone plus oral azithromycin.

The primary endpoint was microbiological response at the test-of-cure (ToC) visit, occurring three to seven days post-treatment. Gepotidacin demonstrated non-inferiority with a success rate of 92.6%, closely aligning with the 91.2% success rate of the comparator regimen.

Safety and tolerability profiles were consistent with prior Phase I and II studies, with gastrointestinal adverse events being the most commonly reported, mostly of mild or moderate severity.

EAGLE-1 marks the third study showing positive outcomes for gepotidacin, which GSK is investigating not only for gonorrhea but also for uncomplicated urinary tract infections (uUTI). If approved, gepotidacin could be the first oral antibiotic for uUTI in over two decades.