GSK stops effective UTI trials early, plans FDA submission

Nov. 4, 2022

GSK has announced that two pivotal phase 3 trials evaluating its investigational antibiotic for uncomplicated urinary tract infection (uUTI) will stop enrollment early for efficacy following a recommendation by the independent data monitoring committee.

If approved, gepotidacin would be the first new novel oral antibiotic treatment for uUTIs in over 20 years.

According to GSK, the EAGLE-2 and EAGLE-3 trials met the primary efficacy endpoint of combined clinical and microbiological resolution following treatment at the Test-Of-Cure visit for gepotidacin versus nitrofurantoin — the current front-line medication used to treat UTIs in female adults and adolescents. The data monitoring committee did not identify any safety concerns.

The development of gepotidacin is the result of a 2013 public-private partnership between GSK and BARDA established to support the development of antibiotics to fight antibiotic resistance and bioterrorism.

Every year, more than 1.2 million people worldwide die from antibiotic-resistant infections, and if no action is taken, it’s estimated this number will grow to 10 million per year by 2050. The pace of innovative drug development has slowed to a crawl, while older antibiotics are rapidly losing ground in the fight against bacteria. And the results could be catastrophic for public health.

GSK says it will work with regulatory authorities to commence regulatory filings for gepotidacin in the first half of 2023.