FX.co ★ GSK: Phase III Data Shows Gepotidacin Potential For Uncomplicated Urogenital Gonorrhea Treatment

GSK plc. has announced encouraging results from the crucial phase III EAGLE-1 trial of gepotidacin, a potential pioneering oral antibiotic specifically designed to treat uncomplicated urogenital gonorrhoea in adolescents and adults.

The promising trial results rely on a primary endpoint of microbiological response, essentially the success or failure to eliminate the bacterial cause of gonorrhoea, evaluated at the Test-of-Cure (ToC) visit within 3-7 days post-treatment.

The trial found that gepotidacin (administered orally in two doses of 3,000mg) had a non-inferior success rate of 92.6%, compared to a 91.2% success rate for the combination therapy of intramuscular ceftriaxone (500mg) plus oral azithromycin (1,000mg), the current leading treatment regimen for gonorrhoea.

GSK plc. has noted that the adverse effects and tolerability of gepotidacin in the EAGLE-1 trial aligned with the outcomes observed in the phase I and II trials. The most frequently reported adverse effects in patients receiving gepotidacin were related to the gastrointestinal system. All reported adverse effects were either mild or moderate, with only one severe unrelated event noticed in each treatment group and one unrelated serious incident in the gepotidacin group.

Gonorrhoea is a sexually transmitted infection caused by Neisseria gonorrhoeae bacteria, identified by the World Health Organisation as a priority pathogen. It can infect both genders, and if not properly managed, it can lead to infertility and other sexual and reproductive health issues, including an increased risk of HIV infection.

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