New data released today by GSK show that the oral investigational antibiotic gepotidacin was non-inferior to the current standard treatment for uncomplicated urogenital gonorrhea.
The British drugmaker announced in a press release that results from the phase 3 EAGLE-1 trial showed that two doses of gepotidacin had a 92.6% success rate for the primary end point of microbiologic response at the test-of-cure visit 3 to 7 days after treatment, compared with a 91.2% success rate for intramuscular ceftriaxone and oral azithromycin. The safety and tolerability profile was consistent with results seen in earlier trials.
"These results highlight the potential of gepotidacin as a new oral treatment option given the rising incidence of gonorrhoea worldwide including drug resistant infections," said Chris Corsico, GSK's senior vice president for development. "The imperative for innovative treatments has never been clearer."
First-in-class antibiotic
Gepotidacin is a first-in-class triazaacenaphthylene antibiotic that works by inhibiting bacterial DNA replication. It's also being developed as a treatment for uncomplicated urinary tract infections.
Gonorrhea is one of the most common sexually transmitted infections, with an estimated 82 million cases each year globally. While the combination of ceftriaxone and azithromycin is the recommended treatment for uncomplicated gonorrhea in most countries, rising resistance to both drugs is threatening its effectiveness. And because the Neisseria gonorrhoeae bacterium has developed resistance to every other antibiotic that's been used for treatment, treatment options are limited.
GSK said the results from the EAGLE-1 trial will be presented later this month at the European Society of Clinical Microbiology and Infectious Diseases Global Congress in Barcelona, Spain.
These results highlight the potential of gepotidacin as a new oral treatment option given the rising incidence of gonorrhoea worldwide including drug resistant infections.