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GSK Reports Promising Results from Clinical Trial of Oral Antibiotic for Uncomplicated Urogenital Gonorrhea.

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In the EAGLE-1 Phase III trial, gepotidacin met the primary efficacy endpoint of non-inferiorty to the current leading treatment for uncomplicated urogenital gonorrhea.

Human blood sample in the tube for gonorrhea test. Image Credit: Adobe Stock Images/AGPhotography

Image Credit: Adobe Stock Images/AGPhotography

Results from the EAGLE-1 Phase III trial showed positive data for GSK’s novel antibiotic gepotidacin for the treatment of uncomplicated urogenital gonorrhea. The trial successfully achieved its primary efficacy endpoint, with gepotidacin proving non-inferior to the current leading treatment regimen of intramuscular ceftriaxone combined with oral azithromycin. Trial investigators stated the finding is significant given the rise in cases of gonorrhea globally, with a reported 82 million cases worldwide every year, which has increased by 18% from 2009 to 2021.1

“With rising incidence rates and concern around growing resistance to existing treatments, gonorrhea poses a threat to public health globally,” said Chris Corsico, SVP, development, GSK, in the release. “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.”

Full results of the study are expected to be shared with health authorities and at an upcoming scientific meeting. The company is also in the process of researching and developing the ability of gepotidacin against uncomplicated urinary tract infections (UTIs), with positive data from the EAGLE-2 and EAGLE-3 trials already presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Copenhagen last April.1

In another release, GSK stated that when tested for UTIs, gepotidacin demonstrated non-inferiority to nitrofurantoin, an existing first-line treatment for uncomplicated UTIs. The discovery marks a major milestone, as there hasn’t been a new class of antibiotics for uncomplicated UTIs in over two decades.2

“Despite uncomplicated urinary tract infections being one of the most common infections in women and mounting concern over rising resistance rates to existing treatments, there has been no new class of antibiotics for over 20 years,” Corsico said in the release. “We believe that gepotidacin, if approved, will offer a much-needed additional oral treatment option for patients at risk of treatment failure associated with resistance or recurrence of uUTI. We are committed to working with global regulators to bring this new antibiotic to patients as quickly as possible.”

In terms of safety, gepotidacin’s safety profile was consistent with what has been reported in prior clinical trials, with gastrointestinal events being the most commonly reported adverse effect. The development of gepotidacin has been supported by federal funding from the United States, highlighting the importance it is placing on public health efforts.2

“These results are a significant step forward in an area that has seen very little innovation for decades,” said Florian Martin Erich Wagenlehner, MD, principal investigator for the EAGLE-2 Phase III trial, in the release. “Gepotidacin is the first antibiotic to meet contemporary regulatory criteria, which set a high threshold for the efficacy of treatments in uncomplicated urinary tract infections. Gepotidacin has the potential to offer healthcare professionals another oral option to treat this common community infection.”

References

1. GSK announces positive headline results from EAGLE-1 phase III trial for gepotidacin in uncomplicated urogenital gonorrhoea (GC). GSK. February 26, 2024. Accessed February 26, 2024. 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/

2. Gepotidacin’s positive phase III data shows potential to be the first in a new class of oral antibiotics for uncomplicated urinary tract infections in over 20 years. GSK. April 15, 2023. Accessed February 26, 2024. https://www.gsk.com/en-gb/media/press-releases/gepotidacin-s-positive-phase-iii-data-shows-potential-to-be-the-first-in-a-new-class-of-oral-antibiotics-for-uncomplicated-urinary-tract-infections/

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