GSK Reports Positive Phase 3 Data for UTI Oral Antibiotic

By Elena Vardon

GSK PLC on Monday reported positive data from its phase 3 studies for gepotidacin, its late-stage oral antibiotic for uncomplicated urinary-tract infections in female adults and teenagers.

The pharmaceutical giant said the EAGLE-2 and EAGLE-3 phase 3 trials met the primary endpoint of non-inferiority to nitrofurantoin, an existing treatment, demonstrating therapeutic success in 50.6% of patients against 47%. EAGLE-3 showed statistical superiority to nitrofurantoin with 58.5% success compared with 43.6%, it added.

It said it plans to submit it to the U.S. Food and Drug Administration in the second quarter of 2023.

GSK added the data shows potential for what could be the first new oral antibiotic for the common ailment in more than two decades.

Write to Elena Vardon at elena.vardon@wsj.com

(END) Dow Jones Newswires

April 17, 2023 02:36 ET (06:36 GMT)

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