GSK (NYSE:GSK) said it was stopping enrolment early in two phase 3 trials of its antibiotic gepotidacin for female adults and adolescents, uncomplicated urinary tract infection (uUTI) as the studies met their main goals.
The decision was made after recommendation from the Independent Data Monitoring Committee (IDMC) and was based on an interim analysis of efficacy and safety data in over 3000 patients across the trials.
The British pharma giant said the studies, dubbed EAGLE-2 and EAGLE-3, met the main efficacy goal of combined clinical and microbiological resolution after treatment at the Test-Of-Cure (TOC) visit for gepotidacin versus nitrofurantoin in patients with a confirmed uUTI and a uropathogen sensitive to nitrofurantoin.
The IDMC review did not find any safety concerns, the company added.
GSK said the EAGLE-2 and 3 trials were now closed for recruitment and the company plans to submit an application to the U.S. Food and Drug Administration in H1 2023 seeking approval of gepotidacin.
The full results will presented in 2023.
Gepotidacin is being developed under a partnership with the U.S. government’s Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS).
The phase 3 program for gepotidacin in adults and adolescents consists of three trials: EAGLE-1, EAGLE-2, and EAGLE-3.
EAGLE-2 (non-inferiority uUTI trial, 204989) was evaluating gepotidacin (1500mg administered orally twice daily for 5 days) against nitrofurantoin (100mg administered orally twice daily for five days). The study duration for participants was ~28 days.
EAGLE-3 (non-inferiority uUTI trial, 212390) was also also comparing gepotidacin to nitrofurantoin, but the duration for participants was ~28 days up until follow-up.
EAGLE-1 is non-inferiority urogenital gonorrhoea trial which is evaluating gepotidacin against ceftriaxone plus azithromycin in approximately 600 patients with uncomplicated GC caused by the bacterium NG.