GSK plc. (GSK,GSK.L) 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 in adolescents and adults.
The results 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 3-7 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.
The company noted that the safety and tolerability profile of gepotidacin in the EAGLE-1 trial was consistent with results seen in phase I and II trials. The most commonly reported adverse events in gepotidacin subjects were gastrointestinal. All adverse events were mild or moderate except for one severe, unrelated event in each treatment arm and one unrelated serious event in the gepotidacin arm.
Gonorrhoea is a sexually transmitted infection caused by bacteria called Neisseria gonorrhoeae, which has been recognised by the World Health Organisation as a priority pathogen. It affects both men and women and if inadequately treated, it can lead to infertility and other sexual and reproductive health complications. It also increases the risk of HIV infection.
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