[{"orgOrder":0,"company":"Spero Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Spero Completes Patient Enrollment in Pivotal Phase 3 Clinical Trial of Oral Tebipenem HBr vs Intravenous Ertapenem for Complicated UTI","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Spero Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Spero Therapeutics Announces Topline Results from its Phase 3 ADAPT-PO Trial of Tebipenem HBr in Complicated UTI and Acute Pyelonephritis","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase 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Find Clinical Drug Pipeline Developments & Deals for Tebipenem Pivoxil Hydrobromide
SPR994 (tebipenem pivoxil hydrobromide) is an oral antibiotic which is under phase 3 clinical development for the treatment of patients with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP).
SPR994 is Spero’s novel late-stage development asset, an oral formulation tablet of tebipenem pivoxil hydrobromide, a carbapenem antibiotic of the β-lactam class.
Under the terms of the agreement, Spero is responsible for the execution and costs of Phase 3 trial of tebipenem HBr (tebipenem pivoxil hydrobromide), an investigational drug, is being developed as the potentially first oral carbapenem antibiotic for the treatment of cUTI.
Under the licence agreement, Spero will be responsible for the execution and costs of the remaining phase III trial of tebipenem HBr. GSK will be responsible for the execution and costs of additional clinical development, including regulatory submission and commercialisation.
FDA feedback indicates positive results from a single additional Phase 3 clinical trial in patients with complicated urinary tract infection (cUTI), with supportive confirmatory evidence of efficacy could support approval of SPR994 (tebipenem HBr).
Spero’s lead product candidate, tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994), is being developed as the first oral carbapenem antibiotic for use in cUTI, including pyelonephritis.
Spero intends to use the proceeds from the agreement for launch of tebipenem HBr, for a complicated urinary tract infection (cUTI) indication as well as to support the continued clinical development of SPR720 and SPR206.
Presentations will showcase in vitro and in vivo studies of tebipenem HBr for treatment of adults with complicated urinary tract infection (cUTI) and acute pyelonephritis (AP) and highlight additional research on the epidemiology and management of cUTI.
Pivotal Phase 3 clinical trial of oral tebipenem HBr met primary endpoint, demonstrating statistical non-inferiority versus intravenous ertapenem in patients with complicated urinary tract infection and acute pyelonephritis.
Phase 3 clinical trial, ADAPT-PO, is evaluating tebipenem HBr for the treatment of complicated urinary tract infection (cUTI) and acute pyelonephritis (AP).