A new typed of antibiotic being developed by GSK may become the first new treatment in more than 20 years for uncomplicated urinary tract infections (UTIs) in women and girls, researchers said in a report published on Thursday in The Lancet.
In two randomized, controlled trials involving more than 3,000 otherwise healthy adolescent girls and women with urinary tract infections in 15 countries, oral gepotidacin was as effective, or more effective, than the commonly used antibiotic nitrofurantoin.
Trial enrollment was stopped early by an independent monitoring committee due to strong efficacy data, the report noted.
The therapeutic success rates for gepotidacin were 50.6% in the trial dubbed EAGLE-2 and 58.5% in the EAGLE-3 trial. That compared with 47.0% and 43.6% for nitrofurantoin. Statistically, gepotidacin was non-inferior to nitrofurantoin in EAGLE-2 and superior in EAGLE-3.
In test-tube experiments, gepotidacin has been effective against a wide range of UTI-causing bacteria, including increasingly prevalent bugs that are resistant to other antibiotics, the researchers said.
The first-in-class triazaacenaphthylene antibiotic inhibits two key enzymes involved in bacterial DNA replication. Mutations in both enzymes would be needed before bacteria could evade it, the researchers said.
An editorial published with the data said the new antibiotic is likely to be highly anticipated by clinicians who treat patients with uncomplicated urinary tract infections.
“Gepotidacin has the potential to be a valuable new treatment, which is particularly promising for patients who are resistant to other antibiotics or who are intolerant to first-line treatments,” the authors said.
More than half of all women globally are affected by uncomplicated UTIs in their lifetime, GSK has previously said.
The company said it plans to file for U.S. approval for gepotidacin to treat uncomplicated UTIs in the second half of this year.
This newsletter was edited by Bill Berkrot.
