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 half of 2023.
If approved, gepotidacin stands to be the first novel oral antibiotic for uncomplicated urinary tract infections in more than 20 years.
Uncomplicated urinary tract infections are exceptionally common, affecting more than half of women at some point in their lifetime. More than one quarter of women have recurrent uUTIs.
The most common cause of uUTI is Escherichia coli (e. coli) bacteria, which is becoming more resistant to current antibiotics.
“With the number of uUTIs caused by resistance bacteria increasing, new antibiotic treatments are necessary,” said Chris Corsico, SVP, Development, GSK, in a news release. “The IDMC’s recommendation to stop the EAGLE-2 and 3 trials early for efficacy provides GSK with the opportunity to engage regulatory authorities as we work together to bring a new class of antibiotics to patients with uUTIs.”
GSK intends to submit the collective data from the two studies in a peer-reviewed journal in 2023. It also plans on presenting the data at a scientific conference.
In all, gepotidacin has been the subject of roughly 20 clinical trials.
The company’s shares fell 0.82% to $32.85 in afternoon trading.