Spero and GSK Reveal Promising Phase 3 Data for Tebipenem HBr

Spero Therapeutics, Inc. and GSK plc have announced significant findings from their pivotal Phase 3 PIVOT-PO trial, which evaluated the efficacy and safety of tebipenem HBr, an investigational 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 in Atlanta, Georgia.

The PIVOT-PO trial demonstrated that tebipenem HBr has the potential to be the first oral carbapenem antibiotic, addressing a critical need in treating cUTIs. This development is particularly important as cUTIs are a common yet challenging condition to manage, often requiring hospitalization and intravenous antibiotics. The trial’s findings indicate that tebipenem HBr could provide a convenient oral option for patients while maintaining the necessary efficacy.

During the presentation, the companies highlighted the trial’s primary endpoint, which assessed the overall clinical cure rate at the test-of-cure visit. The data showed a statistically significant improvement in patients receiving tebipenem HBr compared to those treated with a control regimen. This positive outcome suggests that tebipenem HBr may be a valuable addition to the existing arsenal of antibiotics for treating complicated urinary infections.

The clinical trial also evaluated the safety profile of tebipenem HBr. Results indicated that the oral antibiotic was well-tolerated among participants, with adverse events consistent with those observed in previous studies. These findings are crucial for healthcare providers considering treatment options for patients with cUTIs.

In light of the growing concern over antibiotic resistance, the introduction of tebipenem HBr could address a pressing public health challenge. The ability to offer an oral carbapenem antibiotic represents a significant advancement in treating bacterial infections that have become increasingly difficult to manage.

Dr. Ankit Mahadevia, Chief Executive Officer of Spero Therapeutics, expressed enthusiasm about the trial results, stating, “The PIVOT-PO trial results affirm our commitment to developing innovative therapies for patients facing serious infections. Tebipenem HBr has the potential to transform the treatment landscape for complicated urinary tract infections.”

As the pharmaceutical industry continues to navigate the complexities of antibiotic resistance, the collaboration between Spero Therapeutics and GSK underscores the importance of innovation in developing effective treatment options. The companies plan to submit the data for regulatory review, aiming to bring tebipenem HBr to market in the near future.

The positive results from the PIVOT-PO trial not only highlight the potential of tebipenem HBr but also reflect the ongoing commitment of both organizations to address unmet medical needs in infectious disease management. As antibiotic resistance remains a global concern, advancements like these could have a substantial impact on patient care.

In summary, the presentation of the Phase 3 data for tebipenem HBr marks a promising step forward in the fight against complicated urinary tract infections. With the potential to be the first oral carbapenem antibiotic, this investigational treatment may soon offer a new avenue for patients in need.