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 enrolled in the study. The IDMC review did not identify any new safety concerns beyond those reported in other studies with tebipenem.
GSK plans to work with US regulatory authorities to include the data as part of a filing in the second half of 2025.
Spero stock had closed at $0.6820, down 2.05% on Tuesday. It has traded in the range of $0.5050 - $1.5300 in the last 1 year.
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