Positive Phase III Data for Tebipenem HBr in Complicated Urinary Tract Infections

GSK plc and Spero Therapeutics announced positive results from the pivotal Phase III PIVOT-PO trial for tebipenem HBr, an investigational oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis. The trial demonstrated non-inferiority of tebipenem HBr compared to intravenous imipenem-cilastatin, with a 58.5% overall success rate versus 60.2% for the comparator. The safety profile was similar to other carbapenem antibiotics, with mild to moderate adverse events such as diarrhea and headache. The trial was stopped early for efficacy in May 2025. GSK plans to submit the data to US regulatory authorities in Q4 2025, potentially making tebipenem HBr the first oral carbapenem antibiotic for cUTIs in the US.