Citing Efficacy, GSK Stops Two Pivotal UTI Antibiotic Trials Early

Citing Efficacy, GSK Stops Two Pivotal UTI Antibiotic Trials Early
  • GSK plc GSK announced that phase 3 EAGLE-2 and EAGLE-3 trials evaluating gepotidacin for uncomplicated urinary tract infection would stop enrolment early for efficacy.
  • The move follows a recommendation by the Independent Data Monitoring Committee (IDMC). 
  • This decision was based on a pre-specified interim analysis of efficacy and safety data in over 3,000 patients across the trials.
  • IDMC flagged that the non-inferiority trials testing GSK’s gepotidacin versus nitrofurantoin already met their primary endpoints in an interim analysis. The IDMC review did not identify any safety concerns.
  • Also read: GSK Lifts Annual Outlook After Robust Vaccines, Specialty Medicine Sales In Q3.
  • The news comes with increasing concerns around drug-resistant UTIs and a lack of new antibiotic options for the common infection.
  • In the two trials, patients got 1,500 mg gepotidacin or 100 mg of nitrofurantoin twice daily for five days.
  • GSK is also testing gepotidacin in gonorrhea (that’s EAGLE-1 trial).
  • The EAGLE-2 and 3 trials are now closed for recruitment, with final study visits and data collection anticipated during the first quarter of 2023. 
  • GSK will work with regulatory authorities to commence regulatory filings for gepotidacin in H1 2023. 
  • The development of gepotidacin results from a public-private partnership between GSK, the U.S. government’s Biomedical Advanced Research and Development Authority (BARDA), established in 2013 to support the development of antibiotics to fight antibiotic resistance and bioterrorism.
  • Price Action: GSK shares are down 0.53% at $32.94 on the last check Thursday.

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