Spero Therapeutics and GSK announced on May 28, 2025, that the pivotal Phase 3 PIVOT-PO trial for tebipenem HBr was stopped early for efficacy. This decision followed a recommendation from an Independent Data Monitoring Committee (IDMC) after a pre-specified interim analysis of data from 1,690 patients.
The trial successfully met its primary endpoint of non-inferiority of tebipenem HBr compared to intravenous imipenem-cilastatin. This was observed in hospitalized adult patients with complicated urinary tract infections (cUTIs), including pyelonephritis, based on overall response at the test-of-cure visit.
The IDMC review identified no new safety concerns beyond those previously reported, with diarrhea and headache being the most common adverse events. GSK plans to collaborate with US regulatory authorities to include this data in a filing during the second half of 2025, positioning tebipenem HBr as a potential first oral carbapenem for cUTIs.
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