17th Apr 2023 08:31
(Alliance News) - GSK PLC on Saturday announced positive phase three data that showed potential for its gepotidacin antibiotic to be the "first" in a new class of oral antibiotics for uncomplicated urinary tract infections in "over 20 years".
The London-based pharmaceutical firm said the Eagle-2 and Eagle-3 trials for gepotidacin met their primary endpoints of non-inferiority to nitrofurantoin, an antibacterial medication used to treat UTIs.
GSK added that the Eagle-3 trial demonstrated "statistical superiority" to nitrofurantoin.
In the Eagle-2 phase three trial, gepotidacin demonstrated therapeutic success in 50.6% of patients, compared to 47% for nitrofurantoin. In the EAGLE-3 phase three trial, gepotidacin showed therapeutic success in 58.5% of patients, compared to 43.6% for nitrofurantoin.
The full results will be submitted for publication in a peer-reviewed scientific journal later this year, GSK said.
The company added that US Food & Drug Administration submission for the antibiotic is planned for the second quarter of 2023.
"We believe that gepotidacin, if approved, will offer a much-needed additional oral treatment option for patients at risk of treatment failure associated with resistance or recurrence of uUTI. We are committed to working with global regulators to bring this new antibiotic to patients as quickly as possible," said Chris Corsico, SVP development at GSK.
Shares in GSK were flat at 1,515.49 pence on Monday morning in London.
By Heather Rydings, Alliance News senior economics reporter
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