GSK, Spero Reveal Full Phase 3 Data for Oral Antibiotic Tebipenem HBr; Regulatory Filing Set for End of 2025

GSK and Spero Therapeutics presented full Phase 3 PIVOT-PO results for oral tebipenem HBr at IDWeek 2025, showing it met the primary endpoint of non-inferiority versus IV imipenem-cilastatin for complicated urinary tract infections (cUTIs)123.

The trial was stopped early for efficacy in May 2025, with overall success rates of 58.5% for tebipenem HBr versus 60.2% for IV imipenem-cilastatin (adjusted difference −1.3%, 95% CI −7.5%, 4.8%)18.

Clinical cure rates were high in both arms:
93.5% for tebipenem HBr and 95.2% for IV therapy; microbiological response occurred in about 60% of patients in each group19.

If approved, tebipenem HBr would be the first oral carbapenem antibiotic available for outpatient or at-home treatment of cUTIs, offering an alternative to inpatient IV therapy279.

GSK plans to include the Phase 3 data in a US regulatory filing targeted for the fourth quarter of 202516.

Sources:

1. https://www.stocktitan.net/news/SPRO/pivot-po-phase-3-data-show-tebipenem-h-br-s-potential-as-the-first-9zh4fohcsxtm.html

2. https://www.biospace.com/press-releases/pivot-po-phase-3-data-show-tebipenem-hbrs-potential-as-the-first-oral-carbapenem-antibiotic-for-patients-with-complicated-urinary-tract-infections-cutis

3. https://www.gsk.com/en-gb/media/press-releases/positive-pivot-po-phase-iii-data-show-tebipenem-hbr-s-potential-as-the-first-oral-carbapenem-antibiotic-for-patients-with-complicated-urinary-tract-infections-cutis/

6. https://www.stocktitan.net/sec-filings/GSK/6-k-gsk-plc-current-report-foreign-issuer-c3dd1014f02b.html

7. https://www.contagionlive.com/view/oral-carbapenem-tebipenem-hbr-demonstrates-non-inferiority-to-iv-therapy-in-phase-iii-pivot-po-trial

8. https://firstwordpharma.com/story/6376803

9. https://www.contemporaryobgyn.net/view/oral-tebipenem-hbr-matches-iv-carbapenem-in-phase-3-cuti-trial