GSK shares positive results from phase 3 trial for gonorrhoea treatment

Betsy Goodfellow | February 27, 2024 | News story | Research and Development |  GSK, Infections and infestations, antibiotic, clinical trial, gonorrhoea 

GSK has announced positive headline results from its phase 3 EAGLE-1 trial for gepotidacin, its potential first-in-class oral antibiotic with a novel mechanism of action for the treatment of uncomplicated urogenital gonorrhoea in adolescent and adult patients.

The trial met its primary efficacy endpoint, demonstrating non-inferiority to intramuscular (IM) ceftriaxone plus oral azithromycin, which is a current leading treatment for gonorrhoea, based on a primary endpoint of microbiological response (success or failure) at the Test-of-Cure (ToC) visit three to seven days after treatment.

The safety and tolerability of the drug remained consistent with results seen in prior phase 1 and 2 trials.

GSK is also in the process of developing the drug for the treatment of uncomplicated urinary tract infections.

Further results from the EAGLE-1 trial are expected to be presented at an upcoming scientific meeting, as well as shared with the relevant global health authorities.

Chris Corsico, senior vice president of development at GSK, commented: “With rising incidence rates and concern around growing resistance to existing treatments, gonorrhoea 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.”

Betsy Goodfellow