GSK’s oral antibiotic candidate gepotidacin has met the primary efficacy endpoint of the EAGLE-1 Phase 3 trial in uncomplicated urogenital gonorrhoea (GC), a sexually transmitted infection caused by the Neisseria gonorrhoeae bacteria.

The late-stage study’s primary efficacy endpoint was achieved with two doses of orally taken 3,000mg of gepotidacin showing non-inferiority compared to intramuscular (IM) ceftriaxone (500mg) plus oral azithromycin (1,000mg), a combined treatment for gonorrhea.

This outcome was determined by the microbiological response, classified as either successful or unsuccessful, during the Test-of-Cure (ToC) visit conducted 3-7 days post-treatment.

GSK development senior vice president Chris Corsico said: “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.”

The safety and tolerability findings of gepotidacin in the EAGLE-1 Phase 3 trial remained consistent with the outcomes observed in the earlier phase I and II trials of gepotidacin.

Gepotidacin, a triazaacenaphthylene antibiotic discovered by GSK scientists, acts as a bactericidal agent by hindering bacterial DNA replication through a unique mechanism of action and binding site.

It offers balanced inhibition of two distinct Type II topoisomerase enzymes, rendering it effective against various target uropathogens such as E. coli, S. saprophyticus, and Neisseria gonorrhoeae.

The drug candidate maintains activity against strains resistant to existing antibiotics. The need for specific mutations in both enzymes underscores the necessity for significant susceptibility to gepotidacin, according to GSK.

GSK is also developing gepotidacin as a possible option in the treatment of uncomplicated urinary tract infections (uUTI).

The EAGLE-3 trial is part of the global Phase 3 clinical programme for gepotidacin in adults and adolescents along with EAGLE-1 and EAGLE-2, which are non-inferiority uUTI trials.