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GSK PLC on Wednesday said it will stop a late-stage trial early for an investigational oral antibiotic to treat complicated urinary tract infections, or cUTIs, after the treatment showed positive results in an interim analysis. The Phase 3 Pivot-Po trial of tebipenem HBr, developed in collaboration with Spero Therapeutics Inc, met its primary endpoint and was recommended to stop early for efficacy by an independent data monitoring committee. The treatment was shown to be non-inferior to intravenous imipenem-cilastatin in hospitalised adults with cUTIs, including pyelonephritis. Tebipenem HBr could become the first oral carbapenem antibiotic approved in the US for patients with cUTIs, GSK said. Current carbapenems are only available intravenously, often requiring hospitalisation. GSK said this contributes to an estimated $6 billion in annual healthcare costs in the US, where around 2.9 million cUTIs are treated each year. ‘Complicated UTIs can have a profound impact on patients and carry a high risk of clinical complications, including sepsis and septic shock,’ said GSK Chief Scientific Officer Tony Wood. ‘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.’ No new safety concerns were identified. GSK said it intends to include the data in a planned regulatory submission to the US Food & Drug Administration in the second half of 2025. GSK holds global commercialisation rights to tebipenem HBr outside of certain Asian territories. Shares in GSK were up 0.1% to 1,449.50 pence in London on Wednesday afternoon. Shares in Spero Therapeutics more than doubled to $2.05 in pre-market trading in New York. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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