GSK shares promising data for gepotidacin antibiotic in gonorrhoea
Clinical ResultPhase 3Phase 1Qualified Infectious Disease Product
GSK on Wednesday spelled out more details on a positive Phase III trial of its investigational antibiotic gepotidacin as a potential new treatment for uncomplicated urogenital gonorrhea.
The roughly 600-patient EAGLE-1 trial, which was toplined earlier this year, met its primary endpoint. Gepotidacin achieved a 92.6% microbiological success rate and demonstrated non-inferiority to the leading combination of intramuscular ceftriaxone plus oral azithromycin, which had 91.2% success rates.
Safety and tolerability of gepotidacin in EAGLE-1 was similar to findings from earlier Phase I and II trials. Adverse events were typically mild or moderate, with the most common side effects being gastrointestinal. There was one severe and one serious event in the gepotidacin arm, although both cases were considered unrelated to the drug. Results will be presented at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) at the end of the month.
Rising drug-resistant infections
Chris Corsico, head of development at GSK, said, "These results highlight the potential of gepotidacin as a new oral treatment option given the rising incidence of gonorrhoea worldwide, including drug-resistant infections." Each year, about 82 million new cases of gonorrhoea occur worldwide, and there has been a 118% increase in reported cases in the US from 2009 to 2021, with about half resistant to at least one antibiotic.
Analysts at Barclays recently highlighted gepotidacin's dual-targeting mechanism against the DNA gyrase and topoisomerase IV enzymes as a key advantage in overcoming antibiotic resistance. They project peak sales could reach £801 million ($996 million) for the first-in-class antibiotic, if approved.
Beyond EAGLE-1, GSK has also reported positive Phase III data from the EAGLE-2 and EAGLE-3 trials evaluating gepotidacin for uncomplicated urinary tract infections (uUTI). The company is gearing up for regulatory submissions; it expects to file for uUTI next half, followed by a submission for urogenital gonorrhoea in 2025.
Elsewhere in its antimicrobials pipeline, GSK struck a licencing deal with Spero Therapeutics in 2022 to add tebipenem HBr, a late-stage antibiotic and potential treatment for complicated UTIs. And last year, it partnered with Scynexis on the antifungal Brexafemme (ibrexafungerp) to treat vulvovaginal candidiasis (VVC) and reduce the incidence of recurrent VVC.
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