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
GSK plc 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 (GC) in adolescents and adults
These results will be presented on 30 April 2024 at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global in Barcelona, Spain.
The results from EAGLE-1 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 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 (AEs) in gepotidacin subjects were gastrointestinal (GI). All AEs were mild or moderate (Grade 1 or 2) except for one severe (Grade 3), unrelated event in each treatment arm and one unrelated serious event in the gepotidacin arm.
There are an estimated 82 million new cases of gonorrhoea globally each year. In the United States, rates of reported gonorrhoea have increased 118% from 2009 to 2021, with 648,056 cases being reported to the US Centers for Disease Control and Prevention (CDC) in 2022. The CDC also reported that approximately half of gonorrhoea cases each year in the US are resistant to one antibiotic.
Chris Corsico, SVP Development, GSK, said: “These results highlight the potential of gepotidacin as a new oral treatment option given the rising incidence of gonorrhoea worldwide including drug resistant infections. 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."
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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