India, May 28 -- Spero Therapeutics, Inc.(SPRO) and GSK plc (GSK) Wednesday reported that the pivotal Phase 3 PIVOT-PO study of tebipenem HBr in complicated urinary tract infections (cUTIs), including pyelonephritis, met its primary goal and will stop early for efficacy. This news sent Spero stock up over 250% in pre-market activity.
The primary end point of the study was 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 decision to stop the study early follows the recommendation of an independent data monitoring committee (IDMC), which completed interim analysis of data from 1,690 patients enro...