EAGLE-1 Phase III data show potential for GSK’s gepotidacin in gonorrhoea

UK pharma major GSK (LSE: GSK) has announced positive results from the pivotal EAGLE-1 Phase III trial for gepotidacin, a potential first-in-class oral antibiotic with a novel mechanism of action for uncomplicated urogenital gonorrhoea (GC) in adolescents and adults.

GSK said the results will be presented on April 30, 2024 at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global in Barcelona, Spain.

The results from EAGLE-1 are based on a primary endpoint of microbiological response (success or failure of eliminating the bacterial cause of gonorrhoea) at the Test-of-Cure (ToC) visit three-seven days after treatment. The trial showed that gepotidacin (oral, two doses of 3,000mg) was non-inferior with 92.6% success rates when compared to 91.2% success rates for intramuscular (IM) ceftriaxone (500mg) plus oral azithromycin (1,000mg) combined therapy, a leading combination treatment regimen for gonorrhoea.