GSK and Spero Therapeutics’ Phase III trial of their oral antibiotic for complicated urinary tract infections (cUTI) will end early after successfully meeting its primary endpoint.
The decision to end the trial, which was investigating tebipenem HBr, was made after a recommendation from an Independent Data Monitoring Committee (IDMC) based on pre-specified interim analysis from the pivotal PIVOT-PO trial (NCT06059846).
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The analysis showed that tebeipenem already met the primary endpoint, demonstrating non-inferiority to intravenous (IV) imipenem-cilastatin in hospitalised adult patients with cUTI, including pyelonephritis.
In the study, 1,690 hospitalised cUTI patients were randomised to receive either oral tebipenem HBr or IV imipenem cilastatin for a total of seven to ten days.
There were no new safety signals in the study, with diarrhoea and headache remaining the two most reported adverse events (AEs) after treatment with tebipenem HBr.
GSK plans to submit to the US Food and Drug Administration (FDA) for regulatory approval of tebipenem HBr by the end of 2025. This was part of an agreement between the companies, which saw Spero take responsibility for the development of the asset while GSK would focus on commercialisation.
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By GlobalDataSpero CEO Esther Rajavelu said: “Achieving the primary endpoint in the PIVOT-PO trial marks a significant milestone for tebipenem HBr. If approved, we believe tebipenem HBr is well-positioned to change the treatment landscape for patients diagnosed with cUTI. We look forward to working with GSK on the next steps for this programme.”
cUTIs are UTIs that carry an increased risk of morbidity and mortality. The current standard of care for cUTI is carbapenem antibiotics, especially if patients become septic or suffer allergies or antibiotic resistance, however, these are only available for IV administration. If approved, Spero said that tebipenem HBr would therefore be the first oral carbapenem antibiotic for US patients with cUTIs. This could benefit the estimated 2.9 million patients diagnosed with cUTIs in the US annually.
Antimicrobial resistance (AMR) is a growing issue that health authorities globally are working together to address. As a result, the development of tebipenem HBr has been supported in part by federal funds from the US Department of Health and Human Services (HHS), the Administration for Strategic Preparedness and Response, and the Biomedical Advanced Research and Development Authority (BARDA).
On 26 May, Roche reported that it was starting a Phase III trial for the antibiotic candidate zosurabalpin, which is being jointly developed with Harvard University, in patients with carbapenem-resistant Acinetobacter baumannii (CRAB) infections.
