GSK PLC (LSE:GSK, NYSE:GSK) said it was calling an early halt to trials of a new treatment for uncomplicated urinary tract infection (uUTI) because it has already proved its efficacy.
An Independent Data Monitoring Committee (IDMC) recommended stopping the EAGLE-2 and EAGLE-3 phase III trials for gepotidacin as they had already met the primary endpoint without any safety concerns.
GSK said it now plans to submit a New Drug Application (NDA) for the drug to the US Food and Drug Administration (FDA) in the first half of 2023.
If approved, gepotidacin would be the first new novel oral antibiotic treatment for uncomplicated urinary tract infections in women and children over 20 years, it added.
This IDMC decision was based on a pre-specified interim analysis of efficacy and safety data in over 3,000 patients across the trials, said the statement.
Chris Corsico, SVP, Development, GSK, added: "Uncomplicated urinary tract infections (uUTI) are the most common outpatient infection with over half of all women developing a uUTI during their lifetime and more than a quarter of women suffering from recurrent uUTIs.
"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."
The EAGLE-2 and 3 trials are now closed for recruitment with full results to be submitted for presentation at a scientific congress and for publication in a peer-reviewed journal in 2023.
Gepotidacin is a joint development between GSK and the US government's Biomedical Advanced Research and Development Authority (BARDA).