GSK (LSE/NYSE:GSK) has announced that it would stop enrolling the pivotal EAGLE-2 and EAGLE-3 studies of the antibiotic gepotidacin based on advice from the independent data monitoring committee.
Gepotidacin is a topoisomerase type II inhibitor.
The EAGLE-2 and EAGLE-3 trials met the primary efficacy endpoint related to combined clinical and microbiological resolution. The EAGLE-2 and EAGLE-3 studies, involving data from more than 3,000 patients, sought to establish non-inferiority to nitrofurantoin for uncomplicated urinary tract infections (uUTIs).
EAGLE-2 and EAGLE-3 provided a test-of-cure (TOC) visit for gepotidacin compared with the traditional antibiotic nitrofurantoin in patients with a uUTI. Patients in the study were confirmed to have a uropathogen sensitive to nitrofurantoin. The data monitoring committee did not note any safety concerns.
GSK is gearing up a New Drug Application for gepotidacin, which it intends to file in the first hal…