GSK's Potential First-in-Class Oral Antibiotic Gepotidacin Meets Primary Endpoint in Pivotal Phase 3 EAGLE-1 Trial for Uncomplicated Urogenital Gonorrhea

Feb 27, 2024 07:44 CST Updated 07:45

GSK

Pharmaceutical R&D Manufacturer

▎WuXiEdited by Kant Content Team

GSK announced today,Potential "First-in-Class" Oral Antibiotic Gepotidacin Achieves Positive Results in the Pivotal Phase 3 Clinical Trial EAGLE-1 for Adolescents and Adults with Uncomplicated Urogenital Gonorrhea.The trial met its primary efficacy endpoint, demonstrating non-inferiority of gepotidacin compared to the commonly used combination treatment of intravenous ceftriaxone plus oral azithromycin. Detailed results from the EAGLE-1 trial will be presented at upcoming scientific conferences and shared with global regulatory authorities.

Gonorrhea is a sexually transmitted infection caused by a bacterium called Neisseria gonorrhoeae. It is estimated that there are 82 million new cases globally each year. Gonorrhea affects both men and women and, if left untreated or improperly treated, can lead to infertility and other sexual and reproductive health complications. It also increases the risk of HIV infection.

Gepotidacin, discovered by GSK scientists, is currently under research.A potential "first-in-class" triazaacenaphthylene antibiotic inhibits bacterial DNA replication through an innovative mechanism of action and binding site, providing a well-balanced inhibition of both types of type II topoisomerases across most pathogens.It is active against most urinary pathogens (such as E. coli and Staphylococcus epidermidis) as well as Neisseria gonorrhoeae (including strains resistant to current antibiotics).

▲Gepotidacin Molecular Structure (Image Source: PubChem)

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 that, if approved,It will become the first new class of oral antibiotics in the uUTI field in more than 20 years.

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References:

[1] GSK announces positive headline results from EAGLE-1 phase III trial for gepotidacin in uncomplicated urogenital gonorrhoea (GC) . Retrieved February 26, 2024, from https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-headline-results-from-eagle-1-phase-iii-trial-for-gepotidacin-in-uncomplicated-urogenital-gonorrhoea-gc/

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