Spero Therapeutics and GSK Report Promising Phase 3 Results for Tebipenem HBr

Spero Therapeutics, Inc. and GSK plc have announced promising results from the pivotal Phase 3 PIVOT-PO trial for **tebipenem HBr**, an investigational oral antibiotic aimed at treating complicated urinary tract infections (cUTIs), including pyelonephritis. The findings were presented on **October 20, 2025**, during a late-breaking oral abstract session at **IDWeek 2025** held in **Atlanta, Georgia**.

The trial evaluated the efficacy and safety of tebipenem HBr, marking a significant step in antibiotic development. Currently, there are no oral carbapenem antibiotics available, making this potential treatment particularly noteworthy for patients suffering from cUTIs. This condition can lead to serious complications if not treated effectively.

The results indicate that tebipenem HBr demonstrated strong efficacy in reducing the symptoms of cUTIs. In the study, patients receiving tebipenem HBr showed a statistically significant improvement compared to those receiving a placebo. These findings suggest that tebipenem HBr could fill a critical gap in the treatment options available for patients with these infections.

As antibiotic resistance continues to rise globally, the need for effective treatments is urgent. **Dr. Ankit Mahadevia**, CEO of Spero Therapeutics, emphasized the importance of this trial in the ongoing fight against resistant infections. “The results from the PIVOT-PO trial underscore our commitment to developing innovative therapies for patients with complicated infections,” he stated.

The trial was conducted under the clinical trial identifier **NCT06059846** and involved multiple sites across various countries, providing a robust dataset to assess the drug’s performance. Safety assessments also revealed that tebipenem HBr was well-tolerated among participants, further supporting its potential as a viable oral treatment option.

With these results, Spero Therapeutics and GSK are now poised to advance towards regulatory submissions, aiming to bring tebipenem HBr to market. The companies hope to address the pressing medical need for effective oral antibiotics in the treatment of cUTIs, particularly for patients unable to receive intravenous therapies.

The significance of this trial extends beyond mere statistics; it represents a potential breakthrough in patient care. By providing an oral alternative to existing treatments, tebipenem HBr could enhance the quality of life for many individuals, allowing them to manage their conditions more effectively at home.

The medical community is eager to see how these findings will influence the future landscape of antibiotic treatment. As the situation continues to evolve, stakeholders are watching closely for regulatory updates and potential approvals.

In summary, the PIVOT-PO trial results underscore the promise of tebipenem HBr as a pioneering oral carbapenem antibiotic. The collaboration between Spero Therapeutics and GSK highlights the ongoing efforts to combat antibiotic resistance and improve treatment options for patients worldwide.