Spero/GSK Phase 3 PIVOT-PO trial for tebipenem HBr meets primary endpoint, stops early for efficacy

Spero Therapeutics, Inc.

Tebipenem HBr met non-inferiority vs IV imipenem-cilastatin in 1,690 cUTI patients; IDMC recommended early stop.
No new safety concerns; diarrhea and headache most common adverse events.
GSK plans FDA filing in second half 2025; could be first oral carbapenem for cUTIs in US.
cUTIs affect ~2.9M US cases/year with >$6B in healthcare costs; IV-only standard currently.
Supported by BARDA funding and QIDP/Fast Track designations from FDA.

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