Spero Therapeutics, Inc. and GSK plc have announced the results of the pivotal phase 3 PIVOT-PO trial, which evaluated tebipenem HBr as an oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis. The findings were shared during a late-breaking oral abstract session at IDWeek 2025 in Atlanta, Georgia, on October 20, 2025.
The trial met its primary endpoint, demonstrating that oral tebipenem HBr is non-inferior to intravenous treatment, indicating significant efficacy. The study was stopped early due to its positive results, emphasizing the potential of tebipenem HBr to become the first oral carbapenem antibiotic.
Data from this trial will be submitted to regulatory authorities to support upcoming regulatory filings. This advancement is crucial as antibiotic resistance remains a pressing global health concern, highlighting the need for effective treatment options for cUTIs.
As the landscape of antibiotic development continues to evolve, tebipenem HBr represents a promising candidate that could provide healthcare professionals with a new oral therapeutic option, potentially improving patient adherence and treatment outcomes in managing urinary tract infections.
