GSK unveils pivotal Phase III win for oral antibiotic tebipenem HBr

GSK (LSE: GSK) and Spero Therapeutics (Nasdaq: SPRO) have unveiled full Phase III data for tebipenem HBr, their oral antibiotic for complicated urinary tract infections (cUTIs). Results from the PIVOT-PO trial showed the treatment matched intravenous imipenem-cilastatin on key efficacy measures, supporting plans for a US filing later this year.

The 1,690-patient study was halted early in May after interim findings demonstrated non-inferiority. Patients receiving oral tebipenem HBr achieved a 58.5% overall success rate, versus 60.2% for those on imipenem-cilastatin.

Tony Wood, chief scientific officer at GSK, said: “These ground-breaking data show for the first time that cUTIs, including pyelonephritis, can be treated with an oral carbapenem antibiotic as effectively as with an intravenous one.” Spero’s chief executive Esther Rajavelu said the results mark “the culmination of years of dedicated work” as both companies prepare for submission to the US Food and Drug Administration in the fourth quarter.