GSK announces positive data for gonorrhoea antibiotic

Bacteria in Petri dishes

Positive results have been announced by GSK for its antibiotic targeting uncomplicated urogenital gonorrhoea (GC) in adolescents and adults.

First results from the EAGLE-1 Phase III trial for gepotidacin show that two oral doses of the antibiotic displayed superior success rates (92.6%) when compared to the combination treatment of ceftriaxone and oral azithromycin, which saw a 91.2% success rate.

Gepotidacin is an investigational bactericidal, first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by a novel mechanism of action and binding site and for most pathogens provides well-balanced inhibition of two different Type II topoisomerase enzymes. This enables the antibiotic to provide activity against most strains of target uropathogens, including isolates resistant to several antibiotics.

Data from the trial show that gepotidacin had a safety and tolerability profile similar with results seen in Phase I and II trials. The most commonly reported adverse events (AEs) in gepotidacin subjects were gastrointestinal (GI). One severe grade three adverse event was reported in each treatment arm and one unrelated serious event was reported in the gepotidacin arm.

The trial included 600 patients with uncomplicated urogenital gonorrhoea and followed previous Phase I and II trials which compared the efficacy and safety of of gepotidacin to nitrofurantoin. The primary endpoint was microbiological response at test-of-cure visit three to seven days after treatment.

Cases of gonorrhoea on the rise

Speaking about the results, Chris Corsico, SVP Development, GSK, said:These results highlight the potential of gepotidacin as a new oral treatment option given the rising incidence of gonorrhoea worldwide including drug resistant infections. The imperative for innovative treatments has never been clearer. We are committed to working with health regulators globally to introduce this potential new antibiotic, focusing on solutions that meet critical patient needs.”

According to the World Health Organisation, there are an estimated 92 million new cases of gonorrhoea each year. The Centers for Disease Control and Prevention (CDC) states that in the US, rates of gonorrhoea have increased 118% from 2009 to 2021. The CDC also states that around half of gonorrhoea cases each year in the US are resistant to one antibiotic.

GSK is also developing gepotidacin for the potential treatment of uncomplicated urinary tract infections (uUTI). If approved, gepotidacin could be the first in a new class of oral antibiotics in uUTI in over 20 years.

Reece Armstrong, Editor, DDW

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