CAMBRIDGE, Mass., May 28, 2025 - Spero Therapeutics Inc. and GSK plc have announced the early conclusion of their pivotal Phase 3 PIVOT-PO trial for tebipenem HBr, an investigational oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis. The trial ended early following a recommendation from an Independent Data Monitoring Committee, which found that the primary endpoint of non-inferiority compared to intravenous imipenem-cilastatin had been met. The trial involved 1,690 patients and did not reveal any new safety concerns. If approved, tebipenem HBr could become the first oral carbapenem antibiotic available for U.S. patients with cUTIs. Data from the trial will be included in a planned FDA filing in the second half of 2025.