Clinical Trials

GSK announces results from phase 3 gonorrhoea treatment trial

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 were expected to be presented at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) 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.
According to the company’s press release, ‘GSK is also developing gepotidacin for the potential treatment of uncomplicated urinary tract infections (uUTI). Positive phase 3 data from the EAGLE-2 and EAGLE-3 trials were presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in April 2023, and published in The Lancet. If approved, gepotidacin could be the first in a new class of oral antibiotics in uUTI in over 20 years. EAGLE-1 is the third positive pivotal trial for gepotidacin’.