Drug company GSK says its investigational drug gepotidacin for treating uncomplicated urinary tract infections in female adults and adolescents is safe and effective.
Last week, GSK announced stopping phase III EAGLE-2 and EAGLE-3 trials evaluating the new antibiotic gepotidacin early for efficacy following a recommendation by the Independent Data Monitoring Committee (IDMC).
The company says IDMC’s decision was based on an analysis of efficacy and safety data in over 3000 patients across the trials.
Gepotidacin, a novel drug that blocks enzymes necessary for bacteria to multiply, is the first new class of oral antibiotics for uncomplicated urinary tract infections (uUTIs) in over 20 years. In the trials, the drug showed efficacy in both treating symptoms and killing the bacteria that cause infections.
“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 with uUTI,” Chris Corsico, SVP, Head of Development at GSK, said in a press release.
Data from the trials show that gepotidacin is at least as effective as nitrofurantoin, a widely used antibiotic to treat urinary tract infections.
GSK plans to work with regulatory authorities to commence regulatory filings for gepotidacin in the first half of 2023.
Everyone can get a UTI, but women are significantly more likely to contract the infection. Nearly 1 in 3 women will have had at least one episode of UTI requiring antimicrobial therapy by the age of 24 years. Almost half of all women will experience a urinary tract infection during their lifetime.
UTIs can affect several parts of the urinary tract, but the most common type is a bladder infection, symptoms of which can include pain or burning while urinating, frequent urination, feeling the need to urinate even when the bladder is empty, bloody urine, and pressure or cramping in the groin or lower abdomen.
The World Health Organization (WHO) warns that antibiotic resistance is rising to “dangerously high levels in all parts of the world.” As antibiotics become less effective, more and more infections are becoming harder or impossible to treat.
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