Spero Therapeutics and GSK Announce Early Completion of Phase 3 PIVOT-PO Trial for Oral Antibiotic Tebipenem HBr Based on Positive Efficacy Results

May 28, 2025

Potential First Oral Carbapenem Antibiotic for Complicated Urinary Tract Infections (cUTIs)

DENVER, Colo., May 28, 2025 (247marketnews.com)- Spero Therapeutics (NASDAQ:SPRO) and GSK (NYSE:GSK) today announced that the pivotal Phase 3 PIVOT-PO trial for tebipenem HBr, an investigational oral antibiotic for complicated urinary tract infections (cUTIs), including pyelonephritis, has been stopped early following a positive efficacy review by an independent data monitoring committee (IDMC).

The trial successfully met its primary endpoint of non-inferiority compared to IV imipenem-cilastatin, demonstrating that oral tebipenem HBr can be just as effective in treating hospitalized adult patients with cUTIs, based on a composite measure of clinical cure and microbiological eradication at the test-of-cure visit.

Tony Wood, GSK’s Chief Scientific Officer, commented, “Complicated UTIs can have a profound impact on patients and carry a high risk of clinical complications, including sepsis and septic shock. Currently many need hospital-based intravenous treatment due to limited oral options for drug-resistant infections, contributing to over $6 billion per year in US healthcare costs. These positive results add to our growing anti-infectives portfolio and reinforce the potential of tebipenem HBr as an effective oral alternative taken at home.”

No new safety concerns were identified, with the most common side effects reported being diarrhea and headache—in line with prior studies.

GSK plans to submit a New Drug Application (NDA) to the U.S. FDA in the second half of 2025, including data from the PIVOT-PO trial.

Tebipenem HBr: A First-of-Its-Kind Oral Treatment for cUTIs

If approved, tebipenem HBr would become the first oral carbapenem antibiotic available in the U.S. for the treatment of cUTIs—a condition that affects nearly 2.9 million patients annually, often requiring hospitalization and IV antibiotics, costing the U.S. healthcare system more than $6 billion per year.

Carbapenems are widely used in severe, resistant infections, but are currently available only as IV therapies. Tebipenem HBr could significantly reduce hospital admissions, improve patient convenience, and lower healthcare costs by offering an effective oral alternative.

About the PIVOT-PO Study (NCT06059846)

  • Design: Global, randomized, double-blind, non-inferiority trial
  • Enrollment: 1,690 adult patients with cUTIs, including pyelonephritis
  • Intervention:
    • Tebipenem HBr: 600 mg orally every 6 hours
    • IV Imipenem-Cilastatin: 500 mg every 6 hours
    • Treatment duration: 7–10 days
  • Primary Endpoint: Overall response (clinical cure + microbiological eradication)
  • Outcome: Non-inferior efficacy, early stop for success recommended by IDMC

Full results will be submitted for scientific conference presentation and peer-reviewed publication.

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