PIVOT-PO – BiotechReality – Information Intelligence System for Biopharma

GSK has reported the early discontinuation of its Phase III PIVOT-PO study of tebipenem HBr, an experimental oral carbapenem antibiotic. The action came after the Independent Data Monitoring Committee (IDMC) found the study to have achieved its pre-specified primary efficacy endpoint, making an early finish possible following encouraging interim results. The PIVOT-PO trial was conducted to determine the safety and efficacy of tebipenem HBr for the treatment of adult patients with complicated urinary tract infections (cUTI) such as acute pyelonephritis. The trial compared tebipenem HBr given orally, which was meant to be an easy and good option for a conventional intravenous (IV) carbapenem treatment. GSK reported that the IDMC based its recommendation on the interim analysis showing that tebipenem HBr achieved the primary endpoint of the trial. The recommendation allowed the trial to be stopped early in order to speed up data analysis and submission to regulatory bodies. Complicated UTIs can have a profound impact on patients and carry a high risk of clinical complications, including sepsis and septic shock. Currently many need hospital-based intravenous treatment due to limited oral options for drug-resistant infections, contributing to over $6 billion per year in US healthcare costs. These positive results add to our growing anti-infectives portfolio and reinforce the potential of tebipenem HBr as an effective oral alternative taken at home Tony Wood We’re proud of today’s positive result for patients diagnosed with cUTI, including pyelonephritis, where oral treatments are much needed. We look forward to working with GSK on next steps for tebipenem HBr, and would like to thank the patients, investigators, and other clinical staff who have participated in PIVOT-PO trial to reach this advanced stage. Esther Rajavelu Tebipenem HBr A late-stage development asset developed in partnership with Spero Therapeutics is tebipenem pivoxil hydrobromide (HBr). The drug tebipenem HBr is being developed to treat pyelonephritis and other cUTIs. GSK and Spero Therapeutics signed an exclusive licensing deal in September 2022 for the development and marketing of tebipenem HBr in all markets, with the exception of a few Asian countries. In accordance with this agreement, GSK has sublicensed back to Spero Therapeutics the rights and obligations to carry out certain development activity, such as the PIVOT-PO Phase III research. Following this, GSK will receive sponsorship of the new drug application (NDA) from Spero Therapeutics. The US FDA has designated Tebipenem HBr as a Qualified Infectious Disease Product (QIDP) and granted it Fast Track status. PIVOT-PO Trial PIVOT-PO is a randomized, double-blind, pivotal Phase III clinical trial that compares oral tebipenem pivoxil HBr to intravenous imipenem in adult hospitalized patients with pyelonephritis and cUTI. For a total of seven to ten days, patients were randomized 1:1 to receive either imipenem-cilastin (500 mg) intravenously every six hours or tebipenem pivoxil (600 mg) orally every six hours. Blinding is maintained with matching placebos. Overall response (composite of clinical cure with microbiological eradication) during the test-of-cure visit is the main effectiveness outcome. An evaluation of non-inferiority in the primary analysis population serves as the trial's primary analysis. Randomization was stratified by age, baseline diagnosis (pyelonephritis or cUTI), and whether or not urinary tract instrumentation was present in the 1690 individuals that were enrolled in the trial. Consult clinicaltrials.gov identifier NCT06059846 for additional information about the trial. Source: GSK Last Modified:

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GSK Announces Early Discontinuation of Phase III PIVOT-PO Study for Tebipenem HBr Due to Positive Efficacy Results

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