GSK, Spero Halt Phase 3 cUTI Antibiotic Trial Early for Efficacy

GSK and Spero Therapeutics have halted their phase III PIVOT-PO trial early after tebipenem hydrobromide (HBr), an investigational oral antibiotic for complicated urinary tract infections (cUTIs), met its primary endpoint of non-inferiority compared to intravenous carbapenem antibiotics. The Independent Data Monitoring Committee found no new safety concerns, with diarrhea and headache as the most common adverse events. If approved, tebipenem HBr would be the first oral carbapenem approved in the United States, potentially reducing hospitalizations and healthcare costs associated with cUTIs, which affect millions annually. GSK plans to submit the trial data to the FDA for approval by the second half of 2025 and will present full results at an upcoming scientific congress. This development marks a significant milestone in providing an oral alternative to intravenous treatments for cUTIs, addressing unmet medical needs and antimicrobial resistance challenges. The collaboration between GSK and Spero combines Spero's development responsibilities with GSK's commercialization capabilities.