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.
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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.