Iterum Therapeutics plc announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under the special protocol assessment (SPA) process on the design, endpoints and statistical analysis of a Phase 3 clinical trial for oral sulopenem etzadroxil- probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTI). The SPA agreement provides that the design and planned analysis of the trial, as set out in the protocol submitted to the FDA, adequately addresses the objectives necessary to support the potential resubmission of the Company's new drug application (NDA) for oral sulopenem. The pivotal study to be conducted pursuant to the SPA agreement is designed as a non-inferiority trial comparing oral sulopenem and Augmentin(R) (amoxicillin/clavulanate) and is entitled A prospective, phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem etzadroxil/probenecid versus oral amoxicillin/clavulanate for treatment of uncomplicated urinary tract infections (uUTI) in adult women.

Patients will be randomized to receive either oral sulopenem twice daily for 5 days or Augmentin(R) twice daily for 5 days. The primary endpoint is the overall response (clinical and microbiologic combined response) at Day 12 of the study. The study is expected to enroll approximately 1,966 patients and is anticipated to start enrolling in the fourth quarter of 2022.