Investing.com -- Shares of Spero Therapeutics , Inc. (NASDAQ: SPRO ) surged 240% after the company, along with its development partner GSK plc (LSE/NYSE:GSK), announced positive results from the pivotal Phase 3 PIVOT-PO trial for tebipenem HBr, an investigational oral antibiotic designed to treat complicated urinary tract infections (cUTIs). The trial, which included 1,690 patients, was stopped early for efficacy following a recommendation from an Independent Data Monitoring Committee (IDMC).
The Phase 3 study successfully met its primary endpoint, demonstrating the non-inferiority of tebipenem HBr to the intravenous antibiotic imipenem-cilastatin in treating hospitalized adult patients with cUTI, including pyelonephritis. The IDMC’s interim analysis did not raise new safety concerns, with diarrhea and headache being the most commonly reported adverse events.
According to a press release dated May 28, 2025, tebipenem HBr could become the first oral carbapenem antibiotic available for patients in the United States, addressing an estimated 2.9 million annual cases of cUTIs. These infections often require hospitalization and contribute to over $6 billion in healthcare costs each year in the U.S.
The CEO of Spero, Esther Rajavelu, expressed that achieving the primary endpoint in the PIVOT-PO trial is a significant milestone for the company. She emphasized the potential of tebipenem HBr to change the treatment landscape for patients with cUTI and pyelonephritis. GSK’s Chief Scientific Officer, Tony Wood, highlighted the profound impact of complicated UTIs on patients and the healthcare system, particularly due to the limited oral options for treating drug-resistant infections.
Full trial results will be submitted for presentation at an upcoming scientific congress and for publication in a peer-reviewed journal. Spero and GSK plan to work with U.S. regulatory authorities to include the data as part of a filing with the FDA in the second half of 2025.
The development of tebipenem HBr has been partially funded by the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201800015C.
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