GSK has halted two phase 3 trials of its uncomplicated urinary tract infection (UTI) treatment early after the antibiotic hit its goals, teeing up the Big Pharma to submit the candidate for FDA approval next year.
The EAGLE-2 and EAGLE-3 trials were expected to evaluate the antibiotic, called gepotidacin, in a total of 5,000 female adolescents and adults. But the independent data monitoring committee decided enrollment could be halted early after an interim analysis of data from over 3,000 participants showed the trials had hit their primary endpoints of combined clinical and microbiological resolution.
The trials compared patients treated with gepotidacin to those treated with the commonly used UTI antibiotic nitrofurantoin to see how the infection had resolved. The committee’s review didn’t identify any safety concerns, GSK noted in a release Wednesday morning.
With recruitment for the two EAGLE trials now closed, final data collection is expected to take place in the first quarter of 2023 ahead of submissions to regulators at some point in the first half of the year.
Gepotidacin is the first in a new class of chemical antibiotics called triazaacenaphthylene bacterial topoisomerase inhibitors. While the company has been tinkering with the asset since 2007, the story really begins in 2013 with a public-private partnership between the Big Pharma and the U.S. government’s Biomedical Advanced Research and Development Authority to develop new weapons in the fight against antibiotic resistance and bioterrorism.
If approved, gepotidacin would be the first new antibiotic hitting the market for UTIs in over 20 years. E. coli is the main cause of uncomplicated UTIs, but the bacteria are showing increasing resistance to currently available antibiotics.
“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,” GSK’s senior vice president for development, Chris Corsico, said in today’s release. “With the number of uUTIs caused by resistance bacteria increasing, new antibiotic treatments are necessary.”
With little return on investment for antibiotics, GSK is one of the last big players still in the game. Despite this, the company clearly has its eye on UTIs, having paid $66 million upfront in September to license Spero Therapeutics’ tebipenem HBr oral tablets, which the FDA refused to approve the first time around until more data were provided.
It marks a successful week so far for the late-stage pipeline at GSK; yesterday, the company announced its respiratory syncytial virus (RSV) vaccine candidate had bagged priority-review status from the FDA. If the candidate gets the green light on the May 3 decision date, it could potentially be the first RSV vaccine to market.