GSK's Positive Results in EAGLE-1 Trial for Gepotidacin in Gonorrhoea

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GSK plc announced positive headline results from the pivotal EAGLE-1 phase III trial for gepotidacin, a potential first-in-class oral antibiotic with a novel mechanism of action for uncomplicated urogenital gonorrhea in adolescents and adults. 

The trial met its primary efficacy endpoint, with gepotidacin (oral, two doses of 3,000mg) demonstrating non-inferiority to intramuscular (IM) ceftriaxone (500mg) plus oral azithromycin (1,000mg), a leading combination treatment regimen for gonorrhea. 

The result is based on a primary endpoint of microbiological response (success or failure) at the Test-of-Cure (ToC) visit 3-7 days after treatment.

Chris Corsico, senior vice president of development at GSK, said: “With rising incidence rates and concern around growing resistance to existing treatments, gonorrhea poses a threat to public health globally. 

These positive headline results demonstrate the potential for gepotidacin to provide a novel oral treatment option in the face of rising resistance and for patients who cannot take other treatments due to allergies or intolerance.”

Gonorrhoea is a sexually transmitted infection caused by bacteria called Neisseria gonorrhoeae. It has been estimated that there are 82 million new cases globally each year. 

Gonorrhea rates in the United States increased by 118% between 2009 and 2021, with 648,056 cases reported to the US Centers for Disease Control and Prevention (CDC) in 2022. 

The fever affects both men and women if not treated properly. , can lead to infertility and other sexual and reproductive health problems. It also increases the risk of HIV infection.

The safety and tolerability profile of gepotidacin in the Phase 3 EAGLE-1 trial was consistent with the results observed in the Phase 1 and 2 gepotidacin trials.