gepotidacin proves itself

gepotidacin proves itself
gepotidacin proves itself

The Netherlands – Oral antibiotic gepotidacin (GSK) is effective against uncomplicated urogenital gonorrhea, phase III study shows EAGLE-1.

Good news as this sexually transmitted infection caused by Neisseria gonorrhoeae can lead to complications including infertility if not treated correctly.

This antibiotic, which inhibits bacterial DNA replication by binding to two different topoisomerases, could prove valuable in the context of antibiotic resistance. According to the Centers for Disease Control (CDC)approximately half of the cases of gonorrhea reported each year in the United States are resistant to an antibiotic.

EAGLE-1 data, presented as part of the global conference of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID/ECCMID), showed that the drug was able to eliminate the pathogen in 92.6% of cases. It was found to be non-inferior to the reference treatment.

EAGLE-1: a non-inferiority trial

Results from the EAGLE-1 study (n=600) are based on the primary endpoint of microbiological response (success or failure in killing the bacteria) 3 to 7 days after treatment. The trial showed that gepotidacin (oral, two doses of 3000 mg) was non-inferior to the combination of intramuscular ceftriaxone (500 mg) and oral azithromycin (1000 mg), one of the main treatment regimens treatment against gonorrhea, with a success rate of 92.6%, compared to the 91.2% success rate of combination therapy.

The safety profile of gepotidacin was consistent with results observed in phase I and II trials. The most commonly reported adverse reactions in subjects treated with gepotidacin were gastrointestinal. All adverse reactions were mild or moderate (grade 1 or 2), with the exception of 3 serious events (grade 3) not related to the treatments.

Three positive pivotal trials

These positive data from EAGLE-1 add to those from phase III trials EAGLE-2 And EAGLE-3 presented at ECCMID 2023, and published in The Lancet .

Previously, the non-inferiority trials EAGLE-2 and EAGLE-3 compared the efficacy and safety of gepotidacin (1,500 mg given orally twice daily for five days) to nitrofurantoin (100 mg administered orally twice daily for five days) in uncomplicated urinary tract infections. In both trials, the duration of participation was approximately 28 days and the primary endpoint was the combined clinical and microbiological response at the follow-up visit (days 10 to 13) in patients with uropathogens susceptible to nitrofurantoin.

“This medication is active against most strains of target uropathogens (such as E.coli And S. saprophyticus) And N. gonorrhoeaeincluding isolates resistant to several antibiotics”, underlined the GSK laboratory in a press release before adding: “If approved, gepotidacin could be the first drug in a new class of oral antibiotics for urinary infections For more than 20 years “.

The development of gepotidacin was funded in whole or in part by federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA) and by federal funds granted by the Defense Threat Reduction Agency.

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