Novel Gonorrhea Oral Treatment Option Performs Well in Phase 3 Study

The U.S. Centers for Disease Control and Prevention (CDC) has confirmed Gonorrhea can be cured with the proper treatment for several years.

However, in 2024, the bacteria causing Gonorrhea is recognized by the World Health Organisation as a priority pathogen, for which resistance to existing treatments is rising.

According to industry news, an innovative product may offer better options than the CDC's recommended therapy (ceftriaxone).

GSK plc announced on February 26, 2024, that they had obtained positive headline results from the pivotal EAGLE-1 phase III trial for gepotidacin.

The clinical 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), which is a leading combination treatment regimen for Gonorrhea.

Gepotidacin is a potential first-in-class oral antibiotic that has a novel mechanism of action for treating uncomplicated urogenital Gonorrhea in adolescents and adults.

In a press release, Chris Corsico, Senior Vice President, Development at GSK, said, "With rising incidence rates and concern around growing resistance to existing treatments, Gonorrhea threatens 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."

Detailed results from the EAGLE-1 trial will be presented at an upcoming scientific meeting and shared with global health authorities.

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.

Recently, repurposed vaccines have shown effectiveness against Gonorrhoea, while vaccine candidates conduct late-stage studies.