GSK announced positive results from a pivotal phase 3 trial for its potential first-in-class oral antibiotic, gepotidacin, for uncomplicated urogenital gonorrhea in adolescents and adults.
The EAGLE-1 non-inferiority trial compared the efficacy and safety of gepotidacin to the current standard of care, ceftriaxone plus azithromycin, in approximately 600 patients with uncomplicated urogenital gonorrhea. In the trial, gepotidacin demonstrated non-inferiority, with a 92.6% success rate compared to a 91.2% success rate for intramuscular ceftriaxone plus oral azithromycin.
Gepotidacin, the result of a 2013 public-private partnership between GSK and BARDA, is an investigational bactericidal, first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by a novel mechanism of action and binding site and provides well-balanced inhibition of two different type II topoisomerase enzymes.
The drug is also in development for uncomplicated urinary tract infections. Last April, GSK
presented positive results from two pivotal phase 3 trials. In the EAGLE-2 trial, gepotidacin demonstrated therapeutic success in 50.6% of patients compared to 47% for nitrofurantoin. In the EAGLE-3 trial, gepotidacin demonstrated therapeutic success in 58.5% of patients compared to 43.6% for nitrofurantoin.
If approved, gepotidacin would be the first in a new class of oral antibiotics for UTIs in over 20 years. When sharing the trial results, GSK had targeted a June 2023 regulatory filing, but has seemingly delayed the submission, later sharing an expected regulatory decision by 2025.
