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GSK reports positive results for gepotidacin in uncomplicated urogenital gonorrhoea from EAGLE-1 phase III trial

GSK plc announced positive outcomes from the pivotal EAGLE-1 phase III trial of gepotidacin, an oral antibiotic targeting urogenital gonorrhea in adults and adolescents. Gepotidacin demonstrated non-inferiority to standard treatment, meeting the primary efficacy endpoint of microbiological response at the Test-of-Cure visit. Gonorrhea, caused by Neisseria gonorrhoeae, is a prevalent sexually transmitted infection, with rising rates in the United States.

Safety findings in EAGLE-1 align with previous trials, ensuring consistent tolerability. Detailed results will be presented at upcoming meetings and shared with health authorities. GSK explores gepotidacin for uncomplicated urinary tract infections, with promising data from EAGLE-2 and EAGLE-3 trials. If approved, gepotidacin could become the first oral antibiotic in uUTI therapy in over two decades.

Funding for gepotidacin's development has been received from federal agencies. GSK's commitment to combating infectious diseases spans over 70 years, reflected in its diverse pipeline of medicines and vaccines. Collaborations with Spero Therapeutics, Inc., and Scynexis aim to expand the portfolio with treatments for urinary tract and fungal infections, reflecting GSK's dedication to innovation and global health.