Spero Therapeutics and GSK Unveil Promising Phase 3 Data for Tebipenem HBr

Spero Therapeutics, Inc. and GSK plc revealed promising efficacy and safety data from their pivotal Phase 3 trial of tebipenem HBr, a potential oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis. The results were presented on October 20, 2025, during a late-breaking oral abstract session at IDWeek 2025 held in Atlanta, Georgia.

The PIVOT-PO trial, identified by the clinical trial number NCT06059846, aimed to evaluate the effectiveness of tebipenem HBr in treating patients suffering from cUTIs. The trial’s positive outcomes indicate that this investigational oral carbapenem antibiotic could represent a significant advancement in the treatment of these infections, which are often challenging to manage.

Results from the trial showed a high success rate in both clinical and microbiological outcomes. According to the data shared, tebipenem HBr demonstrated comparable efficacy to the current standard of care, providing an oral option that could enhance patient compliance and treatment accessibility. This is particularly noteworthy as oral carbapenem options have been limited, making tebipenem HBr a potential first in its class.

The findings come at a crucial time, as the rise of antibiotic-resistant bacteria continues to pose significant challenges in the healthcare landscape. The introduction of tebipenem HBr could offer a new tool in the fight against resistant strains, particularly in patients who may not respond well to traditional therapies.

In a statement, Dr. Ankit Mahadevia, Chief Executive Officer of Spero Therapeutics, expressed optimism about the trial’s results. He noted, “The positive data from the PIVOT-PO trial highlight the potential of tebipenem HBr to fill a critical gap in the treatment of cUTIs. We look forward to further discussions with regulatory agencies regarding the path forward for this innovative therapy.”

GSK’s involvement in the trial underscores its commitment to advancing antibiotic research and development. The collaboration aims to leverage both companies’ strengths in addressing unmet medical needs in infectious diseases.

As antibiotic resistance continues to escalate, the importance of developing new therapies cannot be overstated. The results of the PIVOT-PO trial may pave the way for tebipenem HBr to become a vital asset in treating complicated urinary tract infections, offering hope to patients who face limited options.

Stakeholders in the pharmaceutical industry and healthcare sectors will be closely monitoring the developments following these promising results. Future discussions with regulatory agencies will play a critical role in determining the timeline for potential approvals and market availability. The implications of this trial extend beyond Spero Therapeutics and GSK, potentially impacting patient care and treatment protocols worldwide.