▎WuXiEdited by Kant Content Team

GSK announced today that the potential "first-in-class" oral antibiotic gepotidacin achieved positive results in the pivotal Phase 3 clinical trial EAGLE-1 for adolescents and adults with uncomplicated urogenital gonorrhea.Gepotidacin Achieves 92.6% Microbiological Treatment Success Rate, Meeting Non-Inferiority Criteria Compared to Active Treatment Drugs.

In the EAGLE-1 trial, the safety and tolerability of gepotidacin were consistent with the results from Phase 1 and Phase 2 trials. The most commonly reported adverse events (AEs) in participants were related to the gastrointestinal (GI) system. All adverse events were mild or moderate (Grade 1 or Grade 2).

Gonorrhea is a sexually transmitted infection caused by a bacterium called Neisseria gonorrhoeae, which the World Health Organization lists as a priority pathogen. It affects both men and women and, if left untreated, can lead to infertility and other sexual and reproductive health complications. It also increases the risk of HIV infection. Globally, there are an estimated 82 million new cases of gonorrhea each year. According to research, approximately half of all gonorrhea cases annually develop resistance to one type of antibiotic.

▲Gepotidacin Molecular Structure (Image Source: PubChem)

Gepotidacin, discovered by GSK scientists, is a potential “first-in-class” triazaacenaphthylene antibiotic in development. It inhibits bacterial DNA replication through an innovative mechanism of action and binding site.It provides a well-balanced inhibition of two different types of type II topoisomerases for most pathogens. It is active against most urinary tract pathogens, such as E. coli and Staphylococcus epidermidis, as well as Neisseria gonorrhoeae, including strains resistant to current antibiotics.

GSK is also developing gepotidacin for the treatment of uncomplicated urinary tract infections (uUTI). Positive data from the two Phase III clinical trials, EAGLE-2 and EAGLE-3, have been published in The Lancet. The press release noted,If approved, it will become the first new type of oral antibiotic in the uUTI field in more than 20 years.

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