First Phase III trial of sulopenem + probenecid versus ciprofloxacin to treat women with UTI infections.- Iterum Therapeutics.

Iterum Therapeutics plc , announced its initiation of the first of three Phase III clinical trials. In this trial, known as Sulopenem for Resistant Enterobacteriaceae (SURE) 1 , oral sulopenem etzadroxil combined with probenecid in a bilayer tablet (oral sulopenem) is compared to oral ciprofloxacin in women with uncomplicated urinary tract infections (uUTI). Sulopenem is Iterum�s lead compound and novel antibiotic for the treatment of gram-negative, multi-drug resistant infections.

The SURE 1 trial is a randomized, multi-center, double-blind study to measure efficacy, tolerability, and safety of oral sulopenem vs. oral ciprofloxacin for the treatment of uUTI in adult women. Patients will be randomized to receive either oral sulopenem twice daily for 5 days or oral ciprofloxacin twice daily for 3 days, the approved regimen in uUTI. The study is expected to enroll approximately 1,364 patients and will be conducted under a Special Protocol Assessment (SPA) agreement from the FDA. Iterum expects to announce top-line results from this trial in the second half of 2019. Clinicaltrials.gov identifier is NCT03354598.

The initiation of SURE 1 follows the successful completion of a Phase 1 study that documents the pharmacokinetics of the bilayer tablet which will be used in the clinical trial and is intended for commercial production. Iterum is planning to initiate two additional Phase III clinical trials later this year that will utilize both oral and intravenous sulopenem in complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI). The company expects to file its new drug applications (NDAs) with the FDA by the end of 2019 and has received QIDP designations for its oral and IV formulations for the treatment of uUTI, cUTI and cIAI.