GSK plc (LSE/NYSE: GSK) today announced that the pivotal phase III EAGLE-2 and EAGLE-3 trials evaluating gepotidacin, an investigational treatment for uncomplicated urinary tract infection (uUTI) in female adults and adolescents, will stop enrolment early for efficacy following a recommendation by the Independent Data Monitoring Committee (IDMC).
Chris Corsico, SVP, Development, GSK, said: “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.
There has been no new class of oral antibiotics for uUTI for over 20 years. With the number of uUTIs caused by resistance bacteria increasing, new antibiotic treatments are necessary. The IDMC’s recommendation to stop the EAGLE-2 and 3 trials early for efficacy provides GSK with the opportunity to engage regulatory authorities as we work together to bring a new class of antibiotics to patients with uUTIs.”
Phase 3 clinical trials proved to not only be successful but demonstrated the efficacy of the drug beyond the researchers’ expectations that the trials ended earlier than expected.
Gepotidacin is a novel, investigational bactericidal, first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by a distinct mechanism of action, and equally and independently binds to two different Type II topoisomerase enzymes.
This provides activity against most strains of E. coli and S. saprophyticus, including isolates resistant to current antibiotics, Due to the equal and independent binding at both enzymes, mutations in both enzymes are needed to significantly affect gepotidacin susceptibility.
GSK in antibiotics
GSK has been developing and supplying antibiotics for more than 70 years. Research and development continue to investigate new tools to prevent and mitigate infectious disease – and get ahead of antimicrobial resistance. GSK is already a leader on the Antimicrobial Resistance Benchmark of the Access to Medicine Foundation.
In September 2022, GSK entered into an exclusive licence agreement with Spero Therapeutics to add a late-stage antibiotic, tebipenem HBr for the potential treatment of complicated urinary tract infections (cUTI), to our pipeline. The closing of the transaction is subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.