GSK shares results from phase 3 trial for gonorrhoea treatment
Betsy Goodfellow | April 18, 2024 | News story | Research and Development |Â Â GSK, Reproductive health, clinical trial, gonorrhoea, sexual healthÂ
GSK has announced positive results from its phase 3 EAGLE-1 trial for gepotidacin, a potential first-in-class oral antibiotic for the treatment of uncomplicated urogenital gonorrhoea (GC) in adolescent and adult patients.
Full results from the EAGLE-1 trial are expected to be presented at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) taking place on 30 April 2024 in Barcelona, Spain.
The results centre around a primary endpoint of microbiological response at the Test-of-Cure (ToC) visit three to seven days after treatment. The trial demonstrated that the drug (in oral form, with two doses of 3,000mg) had a non-inferior success rate of 92.6% compared to 91.2% for intramuscular (IM) ceftriaxone (500mg) plus oral azithromycin (1,000mg), a combined therapy that is the leading combination treatment for gonorrhoea.
The safety and tolerability profile of the drug in the EAGLE-1 trial remained consistent with that of the phase 1 and 2 trials, with the most commonly reported adverse events (AEs) being gastrointestinal. These AEs were predominantly mild or moderate, aside from one severe, unrelated event in each treatment arm and one unrelated serious event in the gepotidacin arm.
Chris Corsico, senior vice president of development at GSK, commented: “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.”
Betsy Goodfellow
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