FDA grants Fast Track designation to Oral carbapenem for complicated UTI

The US Food and Drug Administration(FDA) has granted Fast Track designation to Oral carbapenem for complicated UTI and acute pyelonephritis.

Antibiotic resistance is one of the most troubling concerns in case of Complicated Urinary Tract Infection (cUTI) acquired through drug-resistant E.coli. But now an investigational oral carbapenem antibiotic has got Fast Tract designation from FDA for treatment of complicated urinary tract infection (cUTI) and acute pyelonephritis. Sapro Therapeutic, the manufacturer of the drug has announced the approval.

SPR994 is tebipenem pivoxil hydrobromide is 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 has been already given Qualified Infectious Disease Product (QIDP) designation.

Fast track is a process designed by the FDA to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Drug-resistant bacteria caused nearly 6% of urinary tract infection as per the article published in Annals of Emergency Medicine.

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, multicenter, prospective study designed to assess the efficacy, safety, and pharmacokinetics of tebipenem vs intravenous (IV) ertapenem (standard of care) in patients with cUTI or AP.

The primary endpoint will be the combined clinical and microbiological response at the test of cure with a 10% noninferiority margin vs IV ertapenem. The trial plans to enroll approximately 1200 patients with an initial lead-in cohort of 70 patients to confirm the dose. The drug candidate will receive FDA Priority Review once the New Drug Application (NDA) is submitted. If approved, SPR994 would be the first oral carbapenem antibiotic for use in adults to treat multidrug-resistant Gram-negative infections.

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