GSK halts antibiotic trials early

GSK has halted patient enrolment in trials for a novel antibiotic, the drug and vaccine giant said on Thursday.

The phase III Eagle 2 and Eagle 3 trials are evaluating gepotidacin, an investigational bactericidal antibiotic for treatment of uncomplicated urinary tract infections (uUTIs) in women and female adolescents.

GSK said that enrolment has been stopped early for efficacy following a recommendation by the Independent Data Monitory Committee, based on a pre-specified interim analysis of efficacy and safety data in more than 3,000 patients across the trials. GSK noted that the IDMC had not identified any safety concerns.

Final study visits and data collection for Eagle 2 and 3 are expected to happen during the first quarter of 2023, ahead of a new drug application being submitted to the US Food and Drug Administration in the first half and full results being presented for publication.

Chris Corsico, senior vice president, development, at GSK, said uUTIs were "the most common outpatient infection", with over half of all women developing one during their lifetime, and more than a quarter experiencing recurrent infections.

“There has been no new class of oral antibiotics for uUTI for over 20 years," he added. "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."

GSK increased annual profit guidance for the second time this year on Wednesday, after quarterly revenues were boosted by its new shingles vaccine Shingrix.