Fast track for oral tebipenem to treat UTIJune 11, 2019
The US FDA has granted Fast Track designation to SPR994, an oral carbapenem for complicated UTI and acute pyelonephritis.
SPR994 is tebipenem pivoxil hydrobromide — an oral formulation of tebipenem, an antibiotic in the carbapenem class.
The preclinical models of SPR994 have already shown its efficacy against gram negative bacteria including E. coli, producing extended-spectrum beta-lactamase (ESBLs) and ESBLs producing Klebsiella pneumoniae, similar to IV ertapenem.
The drug has been already given Qualified Infectious Disease Product (QIDP) designation.
Completion of phase 1, double-blind, placebo-controlled, ascending dose, a multi-cohort study has enabled dose selection for the company’s upcoming phase 3 trial, ADAPT-PO. This will be a randomized, double-blind, double-dummy, multicentre, prospective study designed to assess the efficacy, safety, and pharmacokinetics of tebipenem vs intravenous (IV) ertapenem in patients with complicated UTI or AP.