GSK has announced positive data from the Phase III EAGLE-1 clinical trial of gepotidacin, an investigational oral bactericidal triazaacenaphthylene antibiotic, for the treatment of uncomplicated urogenital gonorrhoea (GC) in adolescent and adult patients.
The EAGLE-1 is a non-inferiority GC trial that involved nearly 600 subjects.
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It assessed the efficacy and safety of two 3,000mg doses of gepotidacin versus the current combination treatment regimen for gonorrhoea, which comprises intramuscular (IM) ceftriaxone plus oral azithromycin.
The trial’s primary endpoint was the microbiological response at the test-of-cure (ToC) visit, which occurred three to seven days post-treatment.
According to the findings, gepotidacin was non-inferior, with a success rate of 92.6%, which closely aligned with the 91.2% success rate of the comparator regimen.
Gepotidacin’s safety and tolerability profile in the trial was observed to be in line with prior data from Phase I and II studies.
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By GlobalDataThe most frequently reported adverse events were gastrointestinal, with most events observed to be mild or moderate in severity.
The EAGLE-1 trial marks the third study to yield positive data for gepotidacin.
GSK is not only investigating gepotidacin for gonorrhoea but also for its potential in treating uncomplicated urinary tract infections (uUTI).
If approved, gepotidacin could become the first oral antibiotic for uUTI indication in over two decades.
GSK Development senior vice-president Chris Corsico said: “These results highlight the potential of gepotidacin as a new oral treatment option given the rising incidence of gonorrhoea worldwide, including drug-resistant infections.
“The imperative for innovative treatments has never been clearer. We are committed to working with health regulators globally to introduce this potential new antibiotic, focusing on solutions that meet critical patient needs.”
Last month, the company announced promising results from the Phase III RUBY/ENGOT-EN6/GOG3031/NSGO trial of Jemperli to treat adults with advanced or recurrent endometrial cancer.
