Spero Therapeutics, GSK announce Phase 3 PIVOT-PO trial met primary endpoint

Spero Therapeutics (SPRO) announced that the pivotal Phase 3 PIVOT-PO trial evaluating tebipenem HBr, an investigational oral treatment for complicated urinary tract infections, including pyelonephritis, met its primary endpoint and will stop early for efficacy. The decision follows a recommendation from an Independent Data Monitoring Committee that completed a pre-specified interim analysis of data from 1,690 patients enrolled in the trial. The trial met the primary endpoint of non-inferiority of tebipenem HBr compared to intravenous imipenem-cilastatin in hospitalized adult patients with cUTI, including pyelonephritis, on overall response at the test-of-cure visit. The IDMC review did not identify any new safety concerns beyond what has been reported in other studies with tebipenem, with diarrhea and headache as the two most reported adverse events. GSK (GSK) plans to work with US regulatory authorities to include the data as part of a filing in 2H 2025. Full results will be submitted for presentation at an upcoming scientific congress and for publication in a peer-reviewed journal.