FX.co ★ GSK: Gepotidacin EAGLE-1 Phase III Trial In GC Reports Positive Headline Results

British pharmaceutical company, GSK plc, reported promising preliminary results from their EAGLE-1 Phase III trial of the antibiotic, gepotidacin. This marks a significant development as gepotidacin may be the first oral antibiotic for the treatment of uncomplicated urogenital gonorrhoea in adolescents and adults.

The trial successfully met its primary efficacy endpoint where gepotidacin, taken orally in two dosages of 3,000mg, demonstrated equal effectiveness to the standard gonorrhoea treatment of intramuscular ceftriaxone (500mg) combined with oral azithromycin (1,000mg).

GSK anticipates sharing detailed results from the EAGLE-1 trial at a future scientific conference and with global health authorities. Gonorrhoea, a sexually transmitted infection caused by the Neisseria gonorrhoeae bacteria, has been identified by the World Health Organization as a high-priority pathogen due to increasing resistance to existing treatments.

If not properly treated, gonorrhoea can result in fertility issues and other sexual and reproductive health complications, as well as increased risk for HIV infection. GSK's recent trial results were based on a primary endpoint of successful or failed microbiological response following treatment.

The safety and tolerability profile of gepotidacin in the EAGLE-1 Phase III trial showed a consistency with results from previous Phase I and II trials of gepotidacin.

"With rising incidence rates and concern around growing resistance to existing treatments, gonorrhoea poses a threat to public health globally," said Chris Corsico, Senior Vice President of Development at GSK. He added that the positive results highlight the potential for gepotidacin to be a new oral treatment alternative, especially for patients unable to take other treatments due to allergies or intolerance.

Meanwhile, GSK's new antibiotic is also undergoing trials for the treatment of uncomplicated urinary tract infections.