Spero Therapeutics and GSK Reveal Efficacy and Safety Outcomes of PIVOT-PO Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Oct 21 2025
0mins
Trial Results: Spero Therapeutics and GSK announced that the phase 3 PIVOT-PO trial for tebipenem HBr, an oral treatment for complicated urinary tract infections, showed non-inferiority to intravenous imipenem-cilastatin, with overall success rates of 58.5% and 60.2%, respectively.
Safety Profile: The safety profile of tebipenem HBr was similar to other carbapenem antibiotics, with mild to moderate adverse events primarily including diarrhea and headache.
Secondary Endpoints: Clinical cure rates were 93.5% for tebipenem HBr versus 95.2% for imipenem-cilastatin, while microbiological response rates were 60.3% and 61.3%, respectively, indicating consistent results in patients with antimicrobial-resistant infections.
Regulatory Plans: GSK plans to submit the trial data to US regulatory authorities in Q4, aiming for tebipenem HBr to become the first oral carbapenem antibiotic in the US for complicated urinary tract infections, addressing antimicrobial resistance challenges.
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About SPRO
Spero Therapeutics, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on identifying and developing novel treatments for rare diseases and diseases caused by multi-drug resistant (MDR) bacterial infections with unmet need. Its product candidate SPR720 is an investigational, chemically stable phosphate ester prodrug that is converted in vivo to SPR719 for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease. Its clinical stage product candidate, tebipenem HBr is an investigational oral carbapenem antibiotic being developed for the treatment of complicated urinary tract infections (cUTIs) including acute pyelonephritis (AP) to help patients potentially reduce duration of in-patient therapy.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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