Phase 3 PIVOT-PO Trial Initiates with First Patient Visit for Tebipenem HBr in cUTI

Spero Therapeutics, a biopharmaceutical firm based in Cambridge, Massachusetts, has embarked on a pivotal Phase 3 clinical trial for tebipenem HBr, an oral antibiotic aimed at treating complicated urinary tract infections (cUTI), including acute pyelonephritis (AP). The trial, known as PIVOT-PO, marks a significant step in the development of what could be the first oral broad-spectrum carbapenem available in the United States for cUTI patients. The oral administration of this drug may offer an alternative to intravenous therapy, potentially benefiting both patients and the healthcare system.

The PIVOT-PO trial is a global, randomized, double-blind study that compares the efficacy of oral tebipenem HBr with that of intravenous imipenem cilastatin in hospitalized adults with cUTI/AP. The trial's primary goal is to assess the overall response, which includes clinical cure and microbiological eradication, at a specific visit post-treatment. The study will enroll approximately 2,648 patients, with a stratified randomization process that considers age, baseline diagnosis, and the presence of urinary tract instrumentation.

Tebipenem HBr, an oral formulation of a carbapenem antibiotic, has been marketed in Japan since 2009 for pediatric infections. Carbapenems are recognized for their safety and efficacy against drug-resistant Gram-negative bacterial infections. If approved, tebipenem HBr could become the first oral carbapenem antimicrobial to receive marketing approval in the U.S. It has already been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA for the treatment of cUTI and AP.

The development of tebipenem HBr has been supported by federal funds from the U.S. Department of Health and Human Services, specifically from the Administration for Strategic Preparedness and Response and the Biomedical Advanced Research and Development Authority.

Spero Therapeutics is also advancing other treatments, such as SPR720, a novel oral therapy candidate for a rare pulmonary disease caused by non-tuberculous mycobacterial infections, and SPR206, an IV-administered next-generation polymyxin product candidate for treating multi-drug resistant Gram-negative infections in hospital settings.

The company's focus on identifying, developing, and commercializing novel treatments for bacterial infections and rare diseases positions it at the forefront of addressing significant unmet medical needs. With the FDA indicating that positive results from the PIVOT-PO trial could support the approval of tebipenem HBr for a limited use indication, Spero Therapeutics continues to drive forward in its mission to bring innovative solutions to patients in need.