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Iterum Therapeutics plc (NASDAQ: ITRM) has agreed with the FDA under the special protocol assessment (SPA) process on the design, endpoints, and statistical analysis of a Phase 3 trial for oral sulopenem etzadroxil-probenecid for uncomplicated urinary tract infections.
The pivotal study under the SPA agreement is designed as a non-inferiority trial comparing oral sulopenem and Augmentin (amoxicillin/clavulanate).
Patients will be randomized to receive either oral sulopenem twice daily for five days or Augmentin twice daily for five days.
The primary endpoint is the overall 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.
The Company has already commenced study start-up activities to enable timely initiation and recruitment.
Price Action: ITRM shares are up 62.10% at $0.39 during the market session on the last check Monday.
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