Spero Therapeutics, Inc. and GSK plc have announced positive results from the pivotal phase 3 PIVOT-PO trial of tebipenem HBr, an experimental oral antibiotic aimed at treating complicated urinary tract infections (cUTIs), including pyelonephritis. These findings were presented during a late-breaking session at IDWeek 2025 held in Atlanta, Georgia, on October 20, 2025.
The trial successfully met its primary endpoint, demonstrating that oral tebipenem HBr is non-inferior to traditional intravenous treatments for the specified infections. Due to the encouraging efficacy results, the study was halted early to allow for the immediate dissemination of the data.
The data gathered during this trial will be submitted to regulatory authorities to support the necessary filings for potential approval of tebipenem HBr as the first oral carbapenem antibiotic.
