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LONDON - GlaxoSmithKline PLC (LSE/NYSE:GSK) has announced the early cessation of its Phase III PIVOT-PO trial for tebipenem HBr, an investigational oral treatment for complicated urinary tract infections (cUTIs), on grounds of efficacy. The Independent (LON:IOG) Data Monitoring Committee (IDMC) recommended halting the trial after a planned interim analysis of data from 1,690 patients. This potentially sets the stage for tebipenem HBr to become the first oral carbapenem antibiotic for cUTIs in the United States.
Tebipenem HBr met the primary endpoint of non-inferiority compared to intravenous imipenem-cilastatin in hospitalized adult patients with cUTIs, including pyelonephritis, based on overall response at the test-of-cure visit. The IDMC did not raise new safety concerns, with diarrhea and headache being the most reported adverse events.
The trial’s positive outcome is significant as cUTIs, often caused by multidrug-resistant pathogens, are estimated to affect 2.9 million cases annually in the U.S. and contribute to more than $6 billion yearly in healthcare costs. Currently, many patients require hospital-based intravenous treatment due to the lack of effective oral options for drug-resistant infections.
GSK’s Chief Scientific Officer, Tony Wood, emphasized the potential of tebipenem HBr as an effective oral alternative that could be taken at home, reducing the need for hospitalization. This aligns with GSK’s focus on addressing the challenges of antimicrobial resistance (AMR) and expanding its anti-infectives portfolio.
Esther Rajavelu, CEO of Spero Therapeutics (NASDAQ:SPRO), the company collaborating with GSK on tebipenem HBr, expressed pride in the trial’s positive outcome and gratitude to the participants involved. The development of tebipenem HBr is partly funded by the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA).
GSK plans to include the data in a U.S. FDA filing in the second half of 2025, with full results to be presented at an upcoming scientific congress and published in a peer-reviewed journal. This announcement is based on a press release statement.
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