Positive EAGLE-1 Phase III trial for GSK’s gepotidacin in urogenital gonorrhoea

UK pharma major GSK (LSE: GSK) today announced positive headline 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 in adolescents and adults.

GSK noted that the trial met its primary efficacy endpoint, with gepotidacin (oral, two doses of 3,000mg) demonstrating non-inferiority to intramuscular (IM) ceftriaxone (500mg) plus oral azithromycin (1,000mg), a leading combination treatment regimen for gonorrhoea. The result is based on a primary endpoint of microbiological response (success or failure) at the Test-of-Cure (ToC) visit 3-7 days after treatment.

"With rising incidence rates and concern around growing resistance to existing treatments, gonorrhoea poses a threat to public health globally. These positive headline results demonstrate the potential for gepotidacin to provide a novel oral treatment option in the face of rising resistance and for patients who cannot take other treatments due to allergies or intolerance," commented Chris Corsico, senior vice president, development at GSK.