Spero Therapeutics, Inc. and GSK plc have announced encouraging results from the pivotal phase 3 PIVOT-PO trial, which evaluated the efficacy and safety of tebipenem HBr, an investigational oral antibiotic aimed at treating complicated urinary tract infections (cUTIs), including pyelonephritis. The findings were presented on October 20, 2025, during a late-breaking oral abstract session at IDWeek 2025 in Atlanta, Georgia.
The study met its primary endpoint by demonstrating the non-inferiority of oral tebipenem HBr when compared to traditional intravenous treatment methods, a significant result given the need for effective oral alternatives in antibiotic therapy.
Due to the trial”s early termination for efficacy, the data will be submitted to regulatory authorities to support the necessary filings for approval.
This development marks a potential breakthrough in the treatment of urinary tract infections, which are among the most common types of infections worldwide, particularly affecting women and the elderly.
The results of the PIVOT-PO trial position tebipenem HBr as a promising candidate in the antibiotic market, particularly as healthcare providers seek to combat rising antibiotic resistance and the limitations of existing therapies.
