Spero and GSK Present Positive Phase 3 Results for Tebipenem HBr

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

The PIVOT-PO trial assessed the efficacy and safety of tebipenem HBr, marking a significant step towards potentially introducing the first oral carbapenem antibiotic to the market. This innovative treatment is particularly crucial for patients who are unable to receive intravenous antibiotics, offering a new option for managing serious infections.

According to the data presented, tebipenem HBr showed a statistically significant improvement in clinical outcomes compared to the standard of care. The trial enrolled a diverse population of participants, ensuring that the results are applicable to a broad range of patients suffering from cUTIs.

The results illustrate that tebipenem HBr not only met the primary endpoint of the trial but also demonstrated a favorable safety profile, with adverse events being consistent with those typically seen in antibiotic treatments. This suggests that tebipenem HBr could be a viable alternative for treating these difficult infections.

Implications for Treatment Options

The introduction of tebipenem HBr could transform the landscape of antibiotic treatments for urinary tract infections. With rising antibiotic resistance, the need for effective oral treatments has become increasingly urgent. The findings from the PIVOT-PO trial provide hope for clinicians and patients alike, as they seek more accessible treatment options.

Spero Therapeutics and GSK plc have expressed enthusiasm regarding the trial outcomes. The companies are now focusing on the next steps toward regulatory submission, which they hope will pave the way for the drug’s approval.

In a statement, Dr. Anjali Kumar, Chief Medical Officer of Spero Therapeutics, emphasized the significance of these results: “The success of the PIVOT-PO trial underscores our commitment to developing innovative therapies that address the pressing needs of patients with complicated urinary tract infections.”

The potential approval of tebipenem HBr would not only mark a milestone for Spero and GSK but also represent an important advance in the ongoing battle against antibiotic-resistant infections.

As the healthcare community anticipates further developments, the successful outcomes of the PIVOT-PO trial could lead to improved treatment protocols and better patient outcomes in the future. The results reinforce the importance of continued research and investment in new antibiotics as part of global health strategies to combat infectious diseases.

In conclusion, the promising results from the Phase 3 trial of tebipenem HBr signify a potential breakthrough in oral antibiotic therapies, offering hope for effective management of complicated urinary tract infections in an era where antibiotic resistance is a growing concern.