GSK, Spero Report Major Phase 3 Win for UTI Antibiotic; Spero’s Stock Surges

GSK and Spero Therapeutics announced positive results for the Phase 3 PIVOT-PO trial of tebipenem HBr, an investigational oral antibiotic for complicated urinary tract infections (cUTI)25.

The trial was stopped early after an interim analysis showed the study met its primary endpoint:
tebipenem HBr was non-inferior to the intravenous antibiotic imipenem-cilastatin in hospitalized adult cUTI patients, including cases of acute pyelonephritis35.

The Independent Data Monitoring Committee recommended stopping the trial early for efficacy, with no new safety concerns identified beyond the known profile; the most common side effects were diarrhea and headache35.

These results set the stage for a New Drug Application (NDA) submission to the FDA in the second half of 2025. If approved, tebipenem HBr would be the first oral carbapenem antibiotic available for cUTI in the U.S., addressing a significant unmet need35.

Following the announcement, Spero Therapeutics' stock price soared 240%, reflecting strong investor confidence in the future of the drug5.

Sources:

2. https://endpts.com/gsk-spero-report-phase-3-win-for-uti-antibiotic-speros-stock-soars/

3. https://www.urologytimes.com/view/phase-3-trial-of-tebipenem-hbr-for-cuti-stopped-early-for-efficacy

5. https://au.investing.com/news/stock-market-news/spero-therapeutics-stock-soars-on-positive-phase-3-trial-results-93CH-3863500