GSK preps filing for novel antibiotic for urinary tract infections

In an encouraging development for the fight against antimicrobial resistance (AMR), GSK’s novel antibiotic gepotidacin has shown efficacy in two phase 3 trials, setting up regulatory filings.

If approved, gepotidacin (GSK2140944) could become the first drug in a new class of oral antibiotics for uncomplicated urinary tract infections (UTIs) in more than 20 years, according to the pharma group, which plans to submit the data to the FDA in the first half of next year.

Crucially, gepotidacin has an entirely new mechanism of action, which should avoid resistance to current antibacterials, inhibiting DNA replication via two different type II topoisomerase enzymes which should make it harder for pathogens to develop resistance.