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Find Clinical Drug Pipeline Developments & Deals by Spero Therapeutics
SPR206 is a novel, intravenously (IV) administered next-generation polymyxin antibiotic for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by MDR Gram-negative bacterial infections.
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).
Tebipenem HBr is an investigational drug in the United States being developed for the treatment of cUTI, including pyelonephritis, caused by certain microorganisms, in adult patients who have limited treatment options; tebipenem HBr is not FDA-approved.
SPR994 (tebipenem pivoxil hydrobromide) is Spero’s novel investigational oral formulation of tebipenem, a carbapenem-class antibiotic in japan it is marketed as Orapenem® since 2009 for pediatric infections limited to pneumonia, otitis media and sinusitis.
Tebipenem HBr is an investigational drug in the United States being developed for the treatment of complicated urinary tract infection, including pyelonephritis, caused by certain microorganisms, in adult patients who have limited oral treatment options.
Oral tebipenem pivoxil hydrobromide, an investigational oral carbapenem antibiotic was noninferior to intravenous ertapenem in the treatment of complicated urinary tract infection and acute pyelonephritis and had a similar safety profile.
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