Spero therapeutics and gsk announce pivot-po phase 3 study for tebipenem hbr stopped early for efficacy following review by independent data monitoring committee

If approved, tebipenem hbr could be the first oral carbapenem antibiotic for us patients with complicated urinary tract infections (cutis) an estimated 2.9 million cases of cutis are treated annually in the us 1 with many cases requiring hospitalization, contributing to over $6 billion per year in healthcare costs 2 data from the pivot-po trial to be part of a planned us food and drug administration (fda) filing in 2h 2025 that spero's development partner, gsk, intends to submit cambridge, mass., may 28, 2025 (globe newswire) -- spero therapeutics, inc. (nasdaq: spro) and gsk plc (lse/nyse: gsk), today announced that the pivotal phase 3 pivot-po trial evaluating tebipenem hbr, an investigational oral treatment for complicated urinary tract infections (cutis), including pyelonephritis, met its primary endpoint and will stop early for efficacy (nct06059846).3 the decision follows a recommendation from an independent data monitoring committee (idmc) that completed a pre-specified interim analysis of data from 1,690 patients enrolled in the trial.
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