Positive Results from EAGLE-1 Phase III Trial Show Potential for Gepotidacin as a Treatment for Uncomplicated Urogenital Gonorrhoea

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GSK has announced positive results from its EAGLE-1 Phase III study (NCT04010539) for gepotidacin, a potential first-in-class antibiotic for the treatment of uncomplicated urogenital gonorrhoea (GC) in adolescents and adults.¹

The primary endpoint for the EAGLE-1 study was microbiological response (success or failure of eliminating the bacterial cause of gonorrhoea) at the Test-of-Cure (ToC) visit 3-7 days after treatment. In line with the primary endpoint, trial data 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.

“These results highlight the potential of gepotidacin as a new oral treatment option given the rising incidence of gonorrhoea worldwide including drug resistant infections,” Chris Corsico, SVP development, GSK said in a press release. “The imperative for innovative treatments has never been clearer. We are committed to working with health regulators globally to introduce this potential new antibiotic, focusing on solutions that meet critical patient needs."

Gepotidacin’s safety and efficacy remained consistent with results previously seen in Phase I and Phase II trials. The most commonly reported adverse events (AEs) in were gastrointestinal. All were mild or moderate except one severe, unrelated event in each treatment arm and one unrelated serious event in the gepotidacin arm.

The EAGLE-1 Phase III trial is a randomized, multicenter, open-label study to evaluate the efficacy and safety of oral gepotidacin compared to intramuscular (IM) ceftriaxone plus oral azithromycin for the treatment of uncomplicated urogenital infection caused by Neisseria gonorrhoeae (N. gonorrhoeae) in adolescent and adult participants. Participants were randomly assigned to receive either oral gepotidacin or IM ceftriaxone plus oral azithromycin.²

Discovered by GSK, gepotidacin is an investigational bactericidal, triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by a novel mechanism of action and binding site and for most pathogens provides well-balanced inhibition of two different Type II topoisomerase enzymes.

In 2020, the World Health Organization estimated 82.4 million new infections with N. gonorrhoeae among adults aged 15 to 49 years.³

References

1. EAGLE-1 phase III data show potential for gepotidacin as a new oral treatment option for uncomplicated urogenital gonorrhoea (GC) amid growing resistance to existing treatments. News release. April 17, 2024. Accessed April 17, 2024. https://www.gsk.com/en-gb/media/press-releases/eagle-1-phase-iii-data-show-potential-for-gepotidacin-as-a-new-oral-treatment-option-for-uncomplicated-gc/

2. A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea. ClinicalTrials.gov. Updated December 14, 2023. Accessed April 17, 2024. https://clinicaltrials.gov/study/NCT04010539

3. Gonorrhoea (Neisseria gonorrhoeae infection). World Health Organization. July 18, 2023. Accessed April 17, 2024. https://www.who.int/news-room/fact-sheets/detail/gonorrhoea-(neisseria-gonorrhoeae-infection)