Footnotes
An investigational oral carbapenem being developed for the treatment of complicated urinary tract infection (cUTI) including pyelonephritis.
Tebipenem HBr is an investigational, novel, oral antibiotic designed to tackle cUTIs including pyelonephritis. Tebipenem HBr belongs to the carbapenem class, which inhibits bacterial cell wall synthesis. If approved by the FDA, it could be the first oral carbapenem available in the U.S. Spero granted GSK an exclusive license to commercialize tebipenem HBr in all territories, except certain Asian territories.
The pivotal PIVOT-PO Phase 3 clinical trial, which began enrollment in January 2024, was designed to evaluate tebipenem HBr in patients with cUTI, including pyelonephritis. Following a pre-specified interim analysis, an Independent Data Monitoring Committee (IDMC) recommended stopping the trial early for efficacy. The analysis confirmed that tebipenem HBr met its primary endpoint, demonstrating non-inferiority to intravenous (IV) imipenem-cilastatin in hospitalized adult patients with cUTI, including pyelonephritis. No new safety concerns were identified beyond previously reported adverse events.
GSK plans to submit the trial data as part of a planned US Food and Drug Administration (FDA) filing in 2H 2025. If approved, tebipenem HBr could change the treatment landscape for cUTI patients, offering a much-needed oral alternative to IV carbapenems.
For more information on the trial, see ClinicalTrials.gov identifier NCT06059846.
An investigational oral candidate designed to treat Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD), a rare disease
SPR720 is a broad spectrum, oral candidate that, if approved, would be a once daily oral treatment for patients with NTM-PD. SPR720 has the potential to be the first approved novel oral agent for NTM-PD, addressing a significant unmet need to treat infection and help prevent further lung damage that the NTM infection causes. SPR720 is currently being evaluated in a Phase 2a trial. For more information on the trial, see ClinicalTrials.gov identifier NCT05496374. Topline data from the Phase 2a proof of concept clinical trial are expected in 4Q 2024.
Spero Therapeutics believes that forming collaborations with external partners is essential to maximizing the reach and impact of our innovative therapies for patients.
Stock information, SEC filings, corporate governance, IR resources and more.
Join our life-changing mission to deliver differentiated treatments to patients suffering with rare diseases and MDR bacterial infections. We seek individuals with unique talents who share our passion.
