Shots:
- GSK & Spero Therapeutics have reported early conclusion of P-III (PIVOT-PO) trial for efficacy of tebipenem HBr to treat cUTIs, incl. pyelonephritis following IDMC recommendation based on positive interim analysis; US FDA’s filing is expected in H2’25
- The P-III (PIVOT-PO) trial assessed tebipenem pivoxil HBr (600mg, PO, every 6hrs.) vs imipenem-cilastin (500mg, IV, every 6hrs.) in hospitalised adults (n=1690) with cUTI incl. pyelonephritis
- Trial met its 1EP, with tebipenem HBr showing non-inferiority to imipenem-cilastatin based on overall response (clinical cure & microbiological eradication) at the test-of-cure visit; data to be incl. in the US FDA’s filing & is planned for future publication & presentation
Ref: GSK| Image: GSK & Spero Therapeutics | Press Release
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