GSK PLC on Thursday said it was stopping enrolment for its gepotidacin antibiotic trial early, following a recommendation by the Independent Data Monitoring Committee.
GSK is a London-based multinational pharmaceutical and biotechnology company. It is currently developing gepotidacin, a novel oral antibiotic treatment for uncomplicated urinary tract infections.
The company said it will stop enrolment for its phase III EAGLE-2 and EAGLE-3 trials early, based on pre-specified interim analysis of efficacy and safety data in over 3000 patients by the IDMC.
Both trials, which compared the efficacy and safety of gepotidacin to nitrofurantoin, met the primary efficacy endpoint of combined clinical and microbiological resolution.
The IDMC review did not flag any safety concerns about the treatment.
As both trials are now closed for recruitment, GSK expects final study visits and data collection during the first quarter of 2023.
The company said it would work with the US Food & Drug Administration to begin regulatory filings for gepotidacin in the first half of next year.
The development of gepotidacin is the result of a public-private partnership between GSK, the US Biomedical Advanced Research & Development Authority and the Defence Threat Reduction Agency.
‘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,’ said Senior Vice President of Development, Chris Corsico.
‘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.’
The annual incidence of uncomplicated UTIs in women is 12% and around 20% in women over 65. Between 30% and 44% of uncomplicated UTI episodes are recurrent.
GSK shares were trading 0.3% higher at 1,450.20 pence each in London on Thursday morning.
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