GSK and Spero Therapeutics on Tuesday announced positive late-stage trial results for their investigational oral antibiotic, tebipenem HBr, for treating complicated urinary tract infections (cUTIs).
The Phase III study, which was stopped early due to its effectiveness, showed the oral drug was as effective as the current standard treatment, an intravenous antibiotic, according to the companies.
If approved, tebipenem HBr would be the first oral carbapenem antibiotic in the U.S. for cUTIs, potentially reducing the need for hospital stays for a condition that costs the U.S. healthcare system over $6 billion annually.
The trial found an overall success rate of 58.5% for patients taking tebipenem HBr, compared with 60.2% for those on the intravenous therapy.
"These ground-breaking data show for the first time that cUTIs, including pyelonephritis, can be treated with an oral carbapenem antibiotic as effectively as with an intravenous one," said Tony Wood, Chief Scientific Officer at GSK.
The company reported that the drug's safety profile was similar to other carbapenems, with the most common side effects being mild to moderate diarrhea and headache.
The announcement adds to GSK's growing portfolio of anti-infectives aimed at addressing antimicrobial resistance.
GSK said it plans to submit the data to U.S. regulators for approval in the fourth quarter of 2025.
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