GSK, Spero End UTI Antibiotic Trial Early After Meeting Goal

GSK and Spero Therapeutics have halted their Phase III trial of tebipenem HBr, an oral antibiotic for complicated urinary tract infections (cUTIs), after interim analysis showed it met its primary endpoint. The PIVOT-PO trial found tebipenem HBr non-inferior to IV imipenem-cilastatin in 1,690 hospitalized adults. Common side effects included diarrhea and headache, with no new safety concerns.

GSK plans to file a New Drug Application with the FDA by the end of 2025. If approved, tebipenem HBr would be the first oral carbapenem available in the U.S. for cUTIs—offering a key alternative to IV therapy for 2.9 million U.S. patients annually. The project received support from BARDA and HHS as part of broader efforts to combat antimicrobial resistance.

03-06-2025