Spero Therapeutics and GSK Announce PIVOT-PO Phase 3 Study for Tebipenem HBr Stopped Early for Efficacy Following Review by Independent Data Monitoring Committee

Core Insights - Spero Therapeutics and GSK announced that the Phase 3 PIVOT-PO trial for tebipenem HBr met its primary endpoint and will stop early for efficacy [1][2][3] Company Overview - Spero Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for rare diseases and multi-drug resistant bacterial infections [10] - GSK is a global biopharma company aiming to unite science, technology, and talent to combat diseases [9] Trial Details - The PIVOT-PO trial evaluated tebipenem HBr against intravenous imipenem-cilastatin in hospitalized adult patients with complicated urinary tract infections (cUTIs) [6][7] - The trial enrolled 1,690 patients and assessed non-inferiority based on a 10% margin [7] - The primary endpoint was the overall response, which is a composite of clinical cure and microbiological eradication [2][7] Market Potential - An estimated 2.9 million cases of cUTIs are treated annually in the US, contributing to over $6 billion in healthcare costs [3][6] - Tebipenem HBr, if approved, could be the first oral carbapenem antibiotic for US patients with cUTIs [6][7] Future Plans - GSK plans to work with US regulatory authorities to include trial data in a filing expected in the second half of 2025 [2][6] - Full results from the trial will be submitted for presentation at a scientific congress and for publication in a peer-reviewed journal [2]