GSK stops two Phase 3 studies for novel antibiotic gepotidacin stopped early

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…

Read more
  • 0