Spero Therapeutics(US:SPRO) Globenewswireยท2025-10-14 12:00Core Insights - Spero Therapeutics is set to present results from the successful Phase 3 PIVOT-PO trial for tebipenem HBr, an investigational oral carbapenem antibiotic for complicated urinary tract infections (cUTI) at the IDWeek annual meeting in October 2025 [1][4] Group 1: Trial Results and Presentations - The Phase 3 PIVOT-PO trial demonstrated non-inferiority of tebipenem HBr compared to intravenous imipenem-cilastatin in hospitalized adult patients with cUTI, including pyelonephritis [4] - An oral presentation titled "Oral Tebipenem Pivoxil Hydrobromide versus Intravenous Imipenem-Cilastatin in Patients with Complicated Urinary Tract Infections or Acute Pyelonephritis" will be given by David K. Hong on October 20, 2025 [2] - Additional posters will cover the in vitro antibacterial spectrum and activity of tebipenem against Enterobacterales clinical isolates causing urinary tract and bloodstream infections [3] Group 2: Product Development and Licensing - Tebipenem HBr is being developed to potentially reduce the duration of inpatient therapy for cUTI [4] - Spero has granted GSK an exclusive license to commercialize tebipenem HBr in most territories, with certain Asian territories licensed to Meiji [4] - The FDA has granted tebipenem HBr Qualified Infectious Disease Product (QIDP) and Fast Track designations, with GSK planning to file for regulatory approval in Q4 2025 [4] Group 3: Company Overview - Spero Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for rare diseases and multi-drug resistant bacterial infections [7] - The company is headquartered in Cambridge, Massachusetts, and aims to address high unmet medical needs in its therapeutic areas [7]