Fast track for oral tebipenem to treat UTI

June 11, 2019 0 By FM

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.